SSTR positive

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.

P2, N=66, Active, not recruiting, Lawson Health Research Institute | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025

P1, N=10, Recruiting, University of Wisconsin, Madison | Not yet recruiting --> Recruiting

P1/2, N=30, Recruiting, The First Affiliated Hospital of Xiamen University | Phase classification: P1 --> P1/2 | N=20 --> 30

Carcinoid crisis is a rare but potentially life-threatening complication of Lutetium-177-Dotatate therapy. Knowledge of risk factors and prompt recognition of symptoms is essential to successful treatment, with early initiation of intravenous octreotide serving a critical step in reducing morbidity of this adverse event.

Yet none of them retained high affinity towards SST2R. We demonstrate for the first time the combination of the amide-to-triazole substitution strategy with alternative stabilization methods to improve the metabolic stability of tumor-targeting peptides.

For NEC, scarce data are available, and pathologic distinction between NEC and NET G3 can be difficult when Ki-67 is below 55%. PRRT could be considered as a treatment for refractory NEC in very selected cases when there is a high uptake on somatostatin receptor imaging, Ki-67 is below 55%, and there is no rapid tumor progression.

P1/2, N=200, Recruiting, Novartis Pharmaceuticals | Trial completion date: May 2028 --> Jun 2029 | Trial primary completion date: May 2025 --> Jun 2029

P=N/A, N=9, Enrolling by invitation, University of California, Davis | Trial completion date: Mar 2025 --> Mar 2026 | Trial primary completion date: Sep 2024 --> Sep 2025

P1/2, N=200, Recruiting, Novartis Pharmaceuticals | N=39 --> 200

P1, N=10, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Recruiting --> Active, not recruiting

P1, N=20, Enrolling by invitation, Yusuf Menda | Active, not recruiting --> Enrolling by invitation | Trial primary completion date: Dec 2023 --> Sep 2025

P1, N=10, Recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Sep 2024 --> Sep 2025 | Trial primary completion date: Sep 2024 --> Sep 2025

P=N/A, N=89, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting | N=50 --> 89

P1/2, N=39, Recruiting, Novartis Pharmaceuticals | Phase classification: P1 --> P1/2

Our study confirms prior work illustrating distinct clinical outcomes in secondary-progressive and de novo World Health Organization grade 3 meningiomas. Furthermore, our findings support (68Ga) DOTATATE PET/MR imaging as a useful management strategy in World Health Organization grade 3 meningiomas and provide insight into meningioma biology, as well as clinical management implications.

P1, N=31, Recruiting, RayzeBio, Inc. | Phase classification: P1b --> P1

P3, N=202, Recruiting, ITM Solucin GmbH | Trial completion date: Sep 2026 --> Sep 2027 | Trial primary completion date: Sep 2024 --> Jun 2027

P1, N=10, Not yet recruiting, University of Wisconsin, Madison | Trial completion date: Oct 2024 --> Mar 2025 | Trial primary completion date: Oct 2024 --> Mar 2025

P=N/A, N=347, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting

P4, N=200, Recruiting, Weill Medical College of Cornell University | Phase classification: P=N/A --> P4

This rare case highlights the pathological complete response of initially unresectable multiple liver metastases achieved by PRRT and SSAs following PNET resection, suggesting their potential as a multimodality treatment option for unresectable PNET.

The study's results suggest that tumor functionality, and certain biomarkers may serve as prognostic survival indicators for patients with NETs undergoing PRRT. The findings can potentially help to identify patients who are at higher risk of disease progression and tailor treatment strategies accordingly.

Oncology nurses provide assessment, education, direct care, and emotional support when caring for patients with GEP-NETs receiving PRRT with 177Lu-DOTATATE. As the treatment landscape evolves, so too will these roles and responsibilities.

P3, N=332, Active, not recruiting, Camurus AB | Recruiting --> Active, not recruiting

PRRT + CAP/TEM represents a highly promising and well-tolerated therapeutic regimen for patients experiencing somatostatin receptor-positive NET with higher (Ki67 ≥ 15%) proliferation rate. Prospective randomized clinical trials are warranted.

A semiquantitative scoring system was used to quantify the severity and frequency of hypoglycemic episodes under background antihypoglycemic therapy (somatostatin analog, diazoxide, everolimus, corticosteroids): score 0, no hypoglycemic episodes; score 1, hypoglycemic events requiring additional conservative treatment with optimization of nutrition; score 2, severe hypoglycemia necessitating hospitalization and combined medication or history of hypoglycemic coma... To our knowledge, our study included the largest cohort of patients with malignant insulinoma to be evaluated. Long-lasting symptom control and reduction of antihypoglycemic medications were shown in most patients after late-line PRRT.

In Korean patients with advanced NETs, Lu-177 DOTATATE PRRT showed efficacy and safety outcomes, consistent with those in the NETTER-1 trial and previous Western real-world studies.

To confirm the patient's eligibility for radical curative treatment, taking into consideration of its neuroendocrine differentiation, a subsequent 18F-AIF-NOTA-octreotide PET/CT was performed, which demonstrated only solitary somatostatin receptor-positive left inguinal mass. The patient underwent radical treatment.

Fluorine-18 is widely used as a radionuclide for the production of radiopharmaceuticals for positron emission tomography (PET). Due to its short half-life (T1/2,109.8 min), its ease of production will facilitate the widespread dissemination of this radiopharmaceutical. A high-quality [AlF]NODA-MPAA-HTA was synthesized with satisfactory yield. This radiopharmaceutical demonstrated higher tumor uptake and better tumor-to-muscle contrast, resulting to excellent image quality. These findings suggest that the novel F-labeled somatostatin analogue, [AlF]NODA-MPAA-HTA, is a promising tool for PET imaging of NETs.

P3, N=45, Completed, Jewish General Hospital | Enrolling by invitation --> Completed | N=75 --> 45 | Trial completion date: Dec 2021 --> Dec 2023 | Trial primary completion date: Dec 2021 --> Dec 2023

The tumors causing TIO exhibited significant heterogeneity in terms of tissue origin, pathological characteristics and biological behavior, but the unique common characteristic is the secretion of FGF23. With significant progress in diagnosis and treatment, the clinical follow-up of most TIO patients shows a good prognosis, but the prognosis of those with malignant tumors is relatively poor.

P4, N=42, Completed, Advanced Accelerator Applications | Recruiting --> Completed

P1, N=10, Not yet recruiting, University of Wisconsin, Madison | Initiation date: Nov 2023 --> Feb 2024

P3, N=309, Active, not recruiting, ITM Solucin GmbH | Trial completion date: Jun 2029 --> Dec 2029 | Trial primary completion date: Jun 2024 --> Dec 2024

[Lu]Lu-satoreotide tetraxetan, administered at a median cumulative activity of 13.0 GBq over three cycles, has an acceptable safety profile with a promising clinical response in patients with progressive, SSTR-positive NETs. A 5-year long-term follow-up study is ongoing.

P=N/A, N=9, Enrolling by invitation, University of California, Davis | Not yet recruiting --> Enrolling by invitation

P1, N=20, Active, not recruiting, Yusuf Menda | Enrolling by invitation --> Active, not recruiting

P2, N=32, Active, not recruiting, Nicholas Fidelman, MD | Trial completion date: Dec 2025 --> May 2026 | Trial primary completion date: Sep 2023 --> May 2024

P1, N=18, Active, not recruiting, Vastra Gotaland Region | Recruiting --> Active, not recruiting | Trial completion date: Jun 2023 --> Jun 2024 | Trial primary completion date: Jun 2022 --> Jun 2024

Our preliminary results demonstrated that [Ga]Ga-FAPI-04 PET/CT mainly failed in well-differentiated NETs refractory to [Lu]Lu-DOTATATE therapy and had a limited role as an alternative diagnostic or theranostic agent. Further investigations with a larger patient population are required to determine the impact of [Ga]Ga-FAPI-04 PET/CT on NETs.

Somatostatin analogs (SSAs) are recommended as first-line systemic therapy for most patients with G1-grade 2 (G2) metastatic well-differentiated GI-NETs. Observation is an option for patients with low-volume or slow-growing disease without symptoms. After progression on SSAs, peptide receptor radionuclide therapy (PRRT) is recommended as systematic therapy for patients with somatostatin receptor (SSTR)-positive tumors. Everolimus is an alternative second-line therapy, particularly in nonfunctioning NETs and patients with SSTR-negative tumors. SSAs are standard first-line therapy for SSTR-positive pancreatic (pan)NETs. Rarely, observation may be appropriate for asymptomatic patients until progression. Second-line systemic options for panNETs include PRRT (for SSTR-positive tumors), cytotoxic chemotherapy, everolimus, or sunitinib. For SSTR-negative tumors, first-line therapy options are chemotherapy, everolimus, or sunitinib. There are insufficient data to recommend particular sequencing of therapies. Patients with G1-G2 high-volume disease, relatively high Ki-67 index, and/or symptoms related to tumor growth may benefit from early cytotoxic chemotherapy. For G3 GEP-NETs, systemic options for G1-G2 may be considered, although cytotoxic chemotherapy is likely the most effective option for patients with tumor-related symptoms, and SSAs are relatively ineffective. Qualifying statements are provided to assist with treatment choice. Multidisciplinary team management is recommended, along with shared decision making with patients, incorporating their values and preferences, potential benefits and harms, and other characteristics and circumstances, such as comorbidities, performance status, geographic location, and access to care.Additional information is available at www.asco.org/gastrointestinal-cancer-guidelines.