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Each patient will undergo one standard of care 18FDG PET/CT and one 64Cu-DOTATATE PET/CT within 4 weeks.

PET/CT scan approximately 60 min after injection of 18F-FDG

18F-FDG

PET/CT scan approximately 60 min after injection of 64Cu-Dotatate

64Cu-Dotatate

Andreas Kjaer, MD

Prospective clinical trial investigating combined, dual 18F-FDG PET/CT and 64Cu-DOTATATE PET/CT imaging of patients with gastroenteropancreatic neuroendocrine neoplasms (GEP-NEN)

Patients with neuroendocrine neoplasms (NEN) represent a heterogeneous disease group with variable prognosis. NEN most frequently arise from the gastrointestinal tract or the pancreas; collectively termed GEP-NEN. Grading of GEP-NEN is based on tumor proliferation index (Ki-67) from biopsies or surgical resection specimens into: low grade G1 neuroendocrine tumor (NET) (Ki-67\<3%), intermediate grade G2 NET (Ki-67 3-20%) and high grade NEN (Ki-67%\>20). High grade NENs are further categorized according to tissue morphology into well-differentiated G3 neuroendocrine tumors (NET) and poorly differentiated neuroendocrine carcinomas (NEC).

A common feature of most NETs is the overexpression of somatostatin receptors (SSR) on the tumor cell surface. Whole-body PET/CT imaging with radiolabelled SSR-targeted tracers, e.g. 64Cu-DOTATATE, plays a key role in diagnosis, staging, treatment selection and response evaluation of patients with NET. Measurements of 64Cu-DOTATATE tumor standardized uptake values (SUV) and tumor volume on PET/CT provide prognostic value for patients with NET. Patients with high grade NEN often have lower SSR expression and SSR PET/CT is infrequently routinely performed in these patients. However, we expect that the SUV and tumor volume from 64Cu-DOTATATE PET/CT also holds prognostic information for patients with high grade NEN and that some patients may prove eligible for PRRT based on the scans.

18F-FDG PET/CT imaging is widely used in cancers, but is routinely primarily reserved for patients with high grade NEN. However, 18F-FDG PET/CT also holds prognostic information for patients with lower grade NET.

By combining 64Cu-DOTATATE PET/CT and 18F-FDG PET/CT imaging, we expect to obtain complementary prognostic information for patients with GEP-NEN of all grades. In this clinical trial, we will therefore investigate and compare the tumor phenotypes found on 64Cu-DOTATATE PET/CT and 18FDG PET/CT performed within 4 weeks in patients with GEP-NET G1-3 and GEP-NEC. The aim of the trial is to establish prognostic models for progression-free-survival (PSF) and overall survival (OS) including tumor status (positive/negative), SUV measurements, and tumor volume derived from the dual 64Cu-DOTATATE PET/CT and 18FDG PET/CT scans.

Dual 64Cu-DOTATATE and 18F-FDG PET/CT Imaging of Patients With Neuroendocrine Neoplasms

Individual participant data are not publicly available due to protection of personal data according to data protection regulations and medical confidentiality.

Time to disease progression from PET/CT scans. Disease progression is defined as a composite measure (whichever occurs first) of RECIST-1.1 defined radiological progression, commencement of another systemic therapy and/or surgery/embolization/ablation related to worsening to the patient's disease status after the index scan, progression evaluated by a multidisciplinary tumor board, and death related to the patient's NEN disease. In case of uncertainty if progression has occurred, the patient's disease status will be evaluated by a multidisciplinary tumor board.

SUV measured on matched tumors on 18F-FDG PET and 64Cu-DOTATATE PET are compared

The proportion of patients who are considered eligible for PRRT based on their 64Cu-DOTATATE PET/CT according to the routine clinical guidelines at the department

Rigshospitalet, Denmark

Digestive System Diseases

Gland and Hormone Related Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Pheochromocytoma

Paraganglioma

Pancreatic Neoplasms

Lung Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Carcinoid Tumor

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Paragangliomas 1

Pancreatic Cancer

Pancreatic Neuroendocrine Tumor

Dose Escalation to determine MTD/MFD in 32 patients receiving up to 4 administrations of \[212Pb\]VMT-α-NET approximately 8 weeks apart.

A dosimetry sub-study utilizing \[203Pb\]VMT-α-NET has been incorporated into the study.

Patients with positive uptake on FDA approved SSTR2 PET/CT will receive a fixed dose of \[212Pb\]VMT-α-NET IV administered every 8 weeks for a maximum of four doses

[212Pb]VMT-α-NET

Patients with positive uptake on FDA approved SSTR2 PET/CT will receive a fixed dose of \[212Pb\]VMT-α-NET IV administered at the RPh2D and schedule determined in Phase I dose escalation

Markus Puhlmann, MD, MBA

Jason Starr, MD

Chih-Yi Liao, MD

Yusuf Menda, MD

Yvonne Taul

Lowell Anthony, MD, FACP

Lilja Solnes, MD

Neda Tehrani

Thorvardur R Halfdanarson, MD

John Crandall

Richard Wahl, MD

Samuel Mehr, MD

This study is Phase I/IIa First-in-Human Study of \[212Pb\]VMT-α-NET Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Neuroendocrine Tumors

This is a prospective, multi-center open-label dose escalation, dose expansion study of \[212Pb\]VMT01 in up to 52 adult subjects with unresectable or metastatic SSTR2-expressing neuroendocrine tumors (NETs) who have not received prior peptide receptor radionuclide therapy (PRRT).

The radioactivity dose escalation period (phase I) tests up to 4 escalating radioactivity dose cohorts of up to 8 subjects (administered at approximately 8-week intervals) at the assigned cohort radioactivity dose.

Pre-specified dose adjustments and individual stopping rules for repeat treatment cycles are based on observed dose-limiting toxicities (DLTs) and adverse events (AEs).

The Maximum Tolerated Dose (MTD) will be determined based on observed DLTs within 42 days of the first treatment cycle.

The recommended expansion dose(s) will be determined following a holistic analysis of observed DLTs, AEs, estimated cumulative organ radiation exposure, and efficacy signals over the course of all treatment cycles for all dose cohorts.

If MTD can not be identified within the 4 radioactivity dose cohorts, a Maximum Feasible Dose (MFD), incorporating manufacturing and logistical considerations for \[212Pb\]VMT-α-NET production, may be determined.

Reno-protective amino acids will be co-administered in a separate IV line prior to each \[212Pb\]VMT-α-NET dose in all subjects. Escalation will be based on a modified toxicity probability interval design \[mTPI-2\] until MTD is identified or the pre-specified rules are met.

A lead-in dosimetry sub-study will be conducted during the dose escalation period in which all subjects in the first two dose cohorts will undergo dosimetric evaluation prior to receiving the therapeutic agent.

A Phase I/IIa First-in-Human Study of \[212Pb\]VMT-α-NET Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Neuroendocrine Tumors

Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Neuroendocrine Tumors

A Phase I/IIa First-in-Human Study of [212Pb]VMT-α-NET Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Neuroendocrine Tumors

Any untoward medical occurrence in a clinical investigational participant administered \[212Pb\]VMT-α-NET and which does not necessarily have a causal relationship with this treatment

Determination of the overall response rate (ORR) by RECIST v1.1 in subjects with neuroendocrine tumors

Biodistribution will be calculated by utilizing SPECT/CT scans.

Perspective Therapeutics

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Infections

Symptoms and General Pathology

Breast Neoplasms

Ovarian Neoplasms

Carcinoma, Merkel Cell

Neoplasms, Unknown Primary

Breast Diseases

Skin Diseases

Neoplasm Metastasis

Neoplastic Processes

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Gonadal Disorders

Communicable Diseases

Polyomavirus Infections

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Ovarian Cancer

Merkel Cell Carcinoma

Somatostatin

Edotreotide

Edotreotide lutetium LU-177

177Lu labeled somatostatin receptors targeting ligand

177Lu-DOTATOC

Ebrahim Delpassand, MD

Rodolfo Nunez, MD

Afshin Shafie, MD

Ayman Gaber, MD

Determine the safety and effectiveness of Lu-177 DOTATOC in adult subjects with somatostatin receptor-expressing Pulmonary, Pheochromocytoma, Paraganglioma, Unknown primary, and Thymus neuroendocrine tumors or any other non-.GEP-NET.

The treatment regimen will consist of 4 doses of 200 (±10%) mCi 177Lu-DOTATOC administered at 8+/- 1-week intervals.

Phase-II Study of Lu177DOTATOC in Adults With STTR(+)Pulmonary, Pheochromocytoma, Paraganglioma, Unknown Primary, Thymus NETs (PUTNET), or Any Other Non-.GEP-NET.

A Phase II, Non-Randomized, Open-Label, Single-center, Physician Sponsored Study to Determine the Safety and Effectiveness of Lu-177 DOTATOC in Adult Subjects With Somatostatin Receptor Expressing Pulmonary, Pheochromocytoma, paragangliomUnknown Primary, and Thymus Neuroendocrine Tumors (PUTNET) or Any Other Non-.GEP-NET.

determined using standard of care scans NETSPOT PET/CT, Octreoscan SPECT/CT, MRI

Excel Diagnostics and Nuclear Oncology Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Dual 64Cu-DOTATATE and 18F-FDG PET/CT Imaging of Patients With Neuroendocrine Neoplasms	NCT05709171	GEP-NET Neuroendocrine ... Neuroendocrine ... Neuroendocrine ...	18F-FDG 64Cu-Dotatate	18 Years -	Rigshospitalet, Denmark
Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Neuroendocrine Tumors	NCT05636618	Neuroendocrine ... Neuroendocrine ... Neuroendocrine ... Neuroendocrine ... Neuroendocrine ... Carcinoid Tumor... Carcinoid Tumor Paraganglioma Pheochromocytom...	[212Pb]VMT-α-NE... [212Pb]VMT-α-NE...	18 Years - 90 Years	Perspective Therapeutics
Phase-II Study of Lu177DOTATOC in Adults With STTR(+)Pulmonary, Pheochromocytoma, Paraganglioma, Unknown Primary, Thymus NETs (PUTNET), or Any Other Non-.GEP-NET.	NCT04276597	Pulmonary Neuro... Pheochromocytom... Paraganglioma Thymus Carcinoi... Unknown Primary... Neuroendocrine ... Neuroendocrine ... Neuroendocrine ... Neuroendocrine ... Neuroendocrine ...	177Lu-DOTATOC	18 Years -	Excel Diagnostics and Nuclear Oncology Center
Phase-II Study of Lu177DOTATOC in Adults With STTR(+)Pulmonary, Pheochromocytoma, Paraganglioma, Unknown Primary, Thymus NETs (PUTNET), or Any Other Non-.GEP-NET.	NCT04276597	Pulmonary Neuro... Pheochromocytom... Paraganglioma Thymus Carcinoi... Unknown Primary... Neuroendocrine ... Neuroendocrine ... Neuroendocrine ... Neuroendocrine ... Neuroendocrine ...	177Lu-DOTATOC	18 Years -	Excel Diagnostics and Nuclear Oncology Center

Spots Global Cancer Trial Database for neuroendocrine carcinoma metastatic