^
    12d
    NeoAdjuvant Theranostic Lutetium Study: The Nautilus Trial (clinicaltrials.gov)
    P1/2, N=36, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Jun 2026 --> Dec 2027 | Trial primary completion date: Jun 2025 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    FOLH1 (Folate hydrolase 1)
    |
    FOLH1 expression
    |
    Firmagon (degarelix)
    12d
    RAD202: HEAT Trial (HER2 Antibody Therapy with Lutetium-177) (clinicaltrials.gov)
    P1, N=35, Recruiting, Radiopharm Theranostics, Ltd | Not yet recruiting --> Recruiting
    Enrollment open
    25d
    Human Epidermal Growth Factor Receptor 2 (HER2) Antibody Therapy with Lutetium-177 in Patients with Advanced Solid Tumours. (ACTRN12625000191493)
    P1, N=24, Not yet recruiting, Radiopharm Theranostics Ltd
    New P1 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    28d
    177Lu-HTK03170 in MCRPC with PSMA Positive Disease (clinicaltrials.gov)
    P1/2, N=50, Suspended, British Columbia Cancer Agency | Recruiting --> Suspended
    Trial suspension
    |
    FOLH1 positive
    1m
    RAD202: HEAT Trial (HER2 Antibody Therapy with Lutetium-177) (clinicaltrials.gov)
    P1, N=35, Not yet recruiting, Radiopharm Theranostics, Ltd
    New P1 trial
    1m
    Evaluating the Safety and Efficacy of 177Lu-LNC1011 Injection in a Single-Center, Single-Arm, Open Study in Patients with Prostate-Specific Membrane Antigen (PSMA)-Positive Metastatic Desmoplasia-Resistant Prostate Cancer (clinicaltrials.gov)
    P=N/A, N=13, Completed, Affiliated Hospital of Jiangnan University
    New trial
    2ms
    177Lu-PSMA (177Lu-PNT2002) in PSMA-Positive Adenoid Cystic Carcinoma (clinicaltrials.gov)
    P2, N=10, Not yet recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Dec 2035 --> Feb 2035 | Initiation date: Dec 2024 --> Mar 2025 | Trial primary completion date: Dec 2030 --> Mar 2030
    Trial completion date • Trial initiation date • Trial primary completion date
    |
    lutetium zadavotide guraxetan (PNT2002)
    3ms
    ZOLAR: 89Zr-olaratumab Dosimetry in Participants With Soft Tissue Sarcoma (clinicaltrials.gov)
    P1, N=50, Recruiting, Telix Pharmaceuticals (Innovations) Pty Ltd | Not yet recruiting --> Recruiting | Initiation date: Aug 2024 --> Oct 2024 | Trial primary completion date: Dec 2025 --> Mar 2026
    Enrollment open • Trial initiation date • Trial primary completion date
    |
    PDGFRA (Platelet Derived Growth Factor Receptor Alpha)
    |
    FOLR1 expression • PDGFRA expression
    |
    Lartruvo (olaratumab)
    3ms
    External Beam Therapy With Theranostic Radioligand Therapy for Oligometastatic Prostate Cancer (ProstACT TARGET) (clinicaltrials.gov)
    P2, N=5, Completed, Telix Pharmaceuticals (Innovations) Pty Limited | Active, not recruiting --> Completed | Trial completion date: Aug 2024 --> Mar 2024
    Trial completion • Trial completion date • Metastases
    |
    177Lu-rosopatamab tetraxetan (TLX591)
    3ms
    Study of the Theranostic Pair RYZ811 (diagnostic) and RYZ801 (therapeutic) to Identify and Treat Subjects with GPC3+ Unresectable HCC (clinicaltrials.gov)
    P1, N=70, Recruiting, RayzeBio, Inc.
    New P1 trial
    |
    GPC3 (Glypican 3)
    3ms
    HER2 Expression Detection and Radionuclide Therapy in Breast Cancer Using 99mTc/188Re Labeled Single Domain Antibody (clinicaltrials.gov)
    P1, N=43, Completed, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Recruiting --> Completed
    Trial completion
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression
    3ms
    Preclinical safety and effectiveness of a long-acting somatostatin analogue [225Ac]Ac-EBTATE against small cell lung cancer and pancreatic neuroendocrine tumors. (PubMed, Eur J Nucl Med Mol Imaging)
    [225Ac]Ac-EBTATE is safe and effective against SCLC and pan-NET and therefore warrants clinical investigation.
    Preclinical • Journal
    |
    SSTR2 (Somatostatin Receptor 2)
    |
    SSTR2 expression • SSTR2 overexpression • SSTR2 underexpression
    |
    EBTATE
    4ms
    PSMA Therapy and Immunotherapy in Kidney Cancer (clinicaltrials.gov)
    P1/2, N=37, Not yet recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Jul 2031 --> Jan 2032 | Initiation date: Nov 2024 --> May 2025 | Trial primary completion date: Jul 2030 --> Jan 2031
    Trial completion date • Trial initiation date • Trial primary completion date • Metastases
    |
    Keytruda (pembrolizumab) • lutetium zadavotide guraxetan (PNT2002)
    4ms
    ProstACT-GLOBAL: The Study of 177Lu-TLX591 Plus SOC Versus SOC Alone in Patients With mCRPC (ProstACT GLOBAL) (clinicaltrials.gov)
    P3, N=430, Recruiting, Telix Pharmaceuticals (Innovations) Pty Limited | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    docetaxel • Xtandi (enzalutamide) • abiraterone acetate • 177Lu-rosopatamab tetraxetan (TLX591)
    5ms
    Molecular theranostics: principles, challenges and controversies. (PubMed, J Med Radiat Sci)
    The prototype molecular theranostic is the 68Ga/177Lu DOTATATE pair that targets somatostatin receptor subtype 2 in neuroendocrine tumors...Despite challenges and limitations, molecular theranostics is a powerful tool in the precision medicine landscape. Molecular theranostics is a vehicle for improved outcomes in cancer patients with a future-facing portfolio of opportunities.
    Journal
    |
    SSTR (Somatostatin Receptor)
    |
    Lutathera (lutetium Lu 177 dotatate)
    5ms
    FAPi Radioligand OpeN-Label, Phase 1 Study to Evaluate Safety, Tolerability and DosImetry of [Lu-177]-PNT6555; A Dose Escalation Study for TReatment of Patients With Select Solid Tumors (FRONTIER) (clinicaltrials.gov)
    P1, N=24, Active, not recruiting, POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company | N=10 --> 24
    Enrollment change
    5ms
    CURLu177PSM0001: 177Lu-PSMA-I&T for Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
    P3, N=439, Active, not recruiting, Curium US LLC | Trial completion date: Jun 2029 --> Feb 2029
    Trial completion date • Metastases
    |
    Xtandi (enzalutamide) • abiraterone acetate • prednisone
    5ms
    Nuclear imaging of PD-L1 expression promotes the synergistic antitumor efficacy of targeted radionuclide therapy and immune checkpoint blockade. (PubMed, Eur J Nucl Med Mol Imaging)
    We developed a novel and long-acting radiotherapeutic agent 177Lu-AB-3PRGD2, and pioneered a strategy guided by PD-L1-targeted nuclear medicine imaging for the combination of TRT and ICB towards precision cancer therapy, optimizing the therapeutic efficacy and reducing the cost and potential toxicity risks. This strategy could also be adapted for clinical practice, combining conventional radiotherapy or chemotherapy with ICB to enhance therapeutic efficacy.
    Journal • Checkpoint inhibition • PD(L)-1 Biomarker • IO biomarker • Checkpoint block
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8)
    |
    PD-L1 expression
    5ms
    A Phase I Study of [177Lu]Lu-FF58 in Patients With Advanced Solid Tumors. (clinicaltrials.gov)
    P1, N=6, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting | N=116 --> 6
    Enrollment closed • Enrollment change • Metastases
    5ms
    Bullseye: Lutetium-177-PSMA-617 in Oligo-metastatic Hormone Sensitive Prostate Cancer (clinicaltrials.gov)
    P2, N=58, Active, not recruiting, Radboud University Medical Center | Recruiting --> Active, not recruiting | Trial completion date: Jan 2025 --> Jan 2026 | Trial primary completion date: Jan 2024 --> Mar 2025
    Enrollment closed • Trial completion date • Trial primary completion date • Metastases
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    5ms
    INDIGO-FAPI: Cutting Edge Imaging With PET-FAPI for Earlier Pancreatic Cancer Diagnosis (clinicaltrials.gov)
    P2, N=35, Not yet recruiting, Institut Curie
    New P2 trial
    |
    177Lu-LNC1004
    5ms
    Preoperative PRRT Versus Surgical Cytoreduction in Metastatic Pancreatic Neuroendocrine Tumors to the Liver (clinicaltrials.gov)
    P1/2, N=0, Withdrawn, University of Chicago | N=52 --> 0 | Trial completion date: Feb 2027 --> Sep 2024 | Recruiting --> Withdrawn | Trial primary completion date: Feb 2027 --> Sep 2024
    Enrollment change • Trial completion date • Trial withdrawal • Trial primary completion date • Metastases
    |
    SSTR2 (Somatostatin Receptor 2)
    |
    SSTR2 expression
    |
    Lutathera (lutetium Lu 177 dotatate)
    5ms
    PSMAddition: An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With SoC, Versus SoC Alone, in Adult Male Patients With mHSPC (clinicaltrials.gov)
    P3, N=1145, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy • Metastases
    |
    FOLH1 positive
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    5ms
    Prognostic value of interim [68Ga]Ga-DOTA-TOC PET/CT in patients with neuroendocrine tumour who underwent peptide receptor radionuclide therapy. (PubMed, Eur Radiol)
    Question Peptide receptor radionuclide therapy is utilised for patients with somatostatin receptor-positive well-differentiated neuroendocrine tumours; however, prognostic predictors are not well established. Findings Progression-free survival was significantly associated with the proportional change in whole tumour volume and total receptor expression between basal and interim [68Ga]Ga-DOTA-TOC PET/CT. Clinical relevance Interim [68Ga]Ga-DOTA-TOC PET/CT can serve as a valuable imaging method to predict prognosis of peptide receptor radionuclide therapy.
    Journal
    |
    SSTR (Somatostatin Receptor)
    |
    SSTR positive
    |
    Lutathera (lutetium Lu 177 dotatate)
    5ms
    Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells (clinicaltrials.gov)
    P2, N=30, Recruiting, National Cancer Institute (NCI) | Trial completion date: Nov 2024 --> Nov 2025 | Trial primary completion date: Nov 2024 --> Nov 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    TP53 (Tumor protein P53) • PTEN (Phosphatase and tensin homolog) • RB1 (RB Transcriptional Corepressor 1) • SYP (Synaptophysin) • CHGA (Chromogranin A)
    |
    Lutathera (lutetium Lu 177 dotatate)
    5ms
    CITADEL-123: Phase 1 Open-label Study of 123I-ATT001 in Subjects with Relapsed Glioblastoma (clinicaltrials.gov)
    P1, N=67, Recruiting, Theragnostics Ltd
    New P1 trial
    5ms
    Dose Finding Study of [177Lu]Lu-NeoB in Newly Diagnosed Glioblastoma and in Recurrent Glioblastoma (clinicaltrials.gov)
    P1, N=48, Recruiting, Novartis Pharmaceuticals | Trial completion date: Jun 2026 --> Aug 2031
    Trial completion date • Combination therapy
    |
    temozolomide • AAA603
    5ms
    Study in Children and Adolescents of 177Lu-DOTATATE (Lutathera®) Combined with the PARP Inhibitor Olaparib for the Treatment of Recurrent or Relapsed Solid Tumours Expressing Somatostatin Receptor (SSTR) (LuPARPed). (clinicaltrials.gov)
    P2, N=25, Recruiting, Fundación de investigación HM | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Lynparza (olaparib) • Lutathera (lutetium Lu 177 dotatate)
    5ms
    ESR Essentials: role of PET/CT in neuroendocrine tumors-practice recommendations by the European Society for Hybrid, Molecular and Translational Imaging. (PubMed, Eur Radiol)
    PRRT utilizes [177Lu]Lu-DOTA-TATE to target the SSR receptor and can significantly prolong progression-free survival in patients with advanced, progressive neuroendocrine tumor of the gastroenteropancreatic system (GEP-NET)...Variable follow-up intervals are recommended for NET G1 and G2. Tumors with higher proliferation rates or advanced metastatic disease necessitate more frequent assessments.
    Review • Journal
    |
    SSTR (Somatostatin Receptor)
    |
    SSTR Expression
    |
    Lutathera (lutetium Lu 177 dotatate)
    5ms
    Using Novel Imaging to More Safely Treat Neuroendocrine Tumors (clinicaltrials.gov)
    P1, N=10, Recruiting, University of Wisconsin, Madison | Not yet recruiting --> Recruiting
    Enrollment open
    |
    SSTR (Somatostatin Receptor)
    |
    SSTR positive
    |
    Lutathera (lutetium Lu 177 dotatate)
    5ms
    Targeted Treatment for Metastatic Prostate Cancer, The PREDICT Trial (clinicaltrials.gov)
    P2, N=474, Not yet recruiting, Alliance for Clinical Trials in Oncology
    New P2 trial
    |
    carboplatin • Xtandi (enzalutamide) • abiraterone acetate • cabazitaxel • Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • Ezharmia (valemetostat)
    6ms
    177Lu-PSMA (177Lu-PNT2002) in PSMA-Positive Adenoid Cystic Carcinoma (clinicaltrials.gov)
    P2, N=10, Not yet recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Initiation date: Sep 2024 --> Dec 2024
    Trial initiation date
    |
    lutetium zadavotide guraxetan (PNT2002)
    6ms
    (SEEtoTREAT): SPECT Imaging for Pharmacokinetics and dosimEtry Towards TREATment Optimization (clinicaltrials.gov)
    P=N/A, N=80, Not yet recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Initiation date: Sep 2024 --> Dec 2024
    Trial initiation date
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • Lutathera (lutetium Lu 177 dotatate) • Xofigo (radium Ra-223 dichloride)
    6ms
    Case Series: ATRX Variants in Four Patients with Metastatic Pheochromocytoma. (PubMed, Front Endocrinol (Lausanne))
    18F-FDOPA PET/CT was found to be the superior functional imaging modality, with 100% lesion detection rate when compared to that of 68Ga-DOTATATE, 18F-FDG, 18F-FDA, and 123I-MIBG scans. While patients did not respond to chemotherapy or tyrosine kinase inhibitors, they responded to targeted radiotherapy using high-specific-activity 131I-MIBG (Azedra®) or 177Lu-DOTATATE (Lutathera®).
    Journal • Metastases
    |
    ATRX (ATRX Chromatin Remodeler)
    |
    Lutathera (lutetium Lu 177 dotatate) • Azedra (iobenguane I 131)
    6ms
    177-Lutetium-PSMA Before Stereotactic Body Radiotherapy for the Treatment of Oligorecurrent Prostate Cancer, The LUNAR Study (clinicaltrials.gov)
    P2, N=93, Active, not recruiting, Jonsson Comprehensive Cancer Center | Trial completion date: Sep 2025 --> Sep 2033 | Trial primary completion date: Sep 2024 --> Sep 2032
    Trial completion date • Trial primary completion date
    |
    lutetium zadavotide guraxetan (PNT2002)
    6ms
    Phase I Study of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers (clinicaltrials.gov)
    P1, N=124, Recruiting, Novartis Pharmaceuticals | Not yet recruiting --> Recruiting
    Enrollment open
    6ms
    Heterogeneous SSTR2 target expression and a novel KIAA1549::BRAF fusion clone in a progressive metastatic lesion following 177Lutetium-DOTATATE molecular radiotherapy in neuroblastoma: a case report. (PubMed, Front Oncol)
    Upon enrollment, the patient received two rounds of the radiolabeled somatostatin analogue lutetium-177 octreotate (177Lu-DOTATATE), which was well tolerated...The observed variation in SSTR2 expression between tumor lesions suggests that heterogeneous target expression may have been the reason for treatment failure in this patient's case. Further investigation within the LuDO-N trial will give a more comprehensive understanding of the correlation between SSTR2 expression levels and treatment outcomes, which will be important to advance treatment strategies based on MRT for children with high-risk NB.
    Journal • Metastases
    |
    BRAF (B-raf proto-oncogene) • KIAA1549 • SSTR (Somatostatin Receptor) • SSTR2 (Somatostatin Receptor 2)
    |
    KIAA1549-BRAF fusion • BRAF fusion • SSTR2 expression • SSTR Expression
    |
    Lutathera (lutetium Lu 177 dotatate)
    6ms
    DATUM: Tumor Absorbed Dose-Response Relationship in Patients Treated With 177Lu-DOTATATE for Meningioma (clinicaltrials.gov)
    P=N/A, N=11, Not yet recruiting, Central Hospital, Nancy, France
    New trial
    |
    Lutathera (lutetium Lu 177 dotatate)
    6ms
    SSTR: Semi-automatic Segmentation Method for Determining 177Lu-DOTATATE Tumor Dosimetry (clinicaltrials.gov)
    P=N/A, N=25, Not yet recruiting, Central Hospital, Nancy, France | Trial completion date: Jul 2024 --> Mar 2025 | Initiation date: Jul 2024 --> Nov 2024 | Trial primary completion date: Jul 2024 --> Jan 2025
    Trial completion date • Trial initiation date • Trial primary completion date
    |
    Lutathera (lutetium Lu 177 dotatate)
    6ms
    PROLUT: Comparison of Changes in Tumor Burden in 68Ga-PSMA-11 PET/CT and 177Lu-PSMA SPECT/CT in Metastatic Castration-resistant Prostate Cancer (clinicaltrials.gov)
    P=N/A, N=80, Not yet recruiting, Central Hospital, Nancy, France | Initiation date: Sep 2024 --> Jan 2025
    Trial initiation date • Metastases
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    6ms
    Study With [225Ac]Ac-FL-020 in mCRPC Participants (clinicaltrials.gov)
    P1, N=35, Recruiting, Full-Life Technologies GmbH | Not yet recruiting --> Recruiting | Initiation date: Jul 2024 --> Oct 2024
    Enrollment open • Trial initiation date
    |
    225Ac-FL-020
    6ms
    Study in Children and Adolescents of 177Lu-DOTATATE (Lutathera®) Combined with the PARP Inhibitor Olaparib for the Treatment of Recurrent or Relapsed Solid Tumours Expressing Somatostatin Receptor (SSTR) (LuPARPed). (clinicaltrials.gov)
    P2, N=25, Not yet recruiting, Fundación de investigación HM
    New P2 trial
    |
    Lynparza (olaparib) • Lutathera (lutetium Lu 177 dotatate)