Loading clinical trials...

SUV on 68Ga-DOTATATE PET/CT and Ki-67 Index in Neuro-Endocrine Tumors | Clinical Trials | Clareo Health

COMPLETEDPHASE3

SUV on 68Ga-DOTATATE PET/CT and Ki-67 Index in Neuro-Endocrine Tumors

Correlation Between SUV on 68Ga-DOTATATE PET/CT and Ki-67 Index in Neuro-Endocrine Tumors

NCT02840149•Jewish General Hospital

Summary

Positron emission tomography/computed tomography (PET/CT) is an advanced nuclear medicine scan. This technology allows precise and early cancer to be visualized and measured on whole body images. Patients with Neuro-Endocrine tumors (NETs), require specialized molecular imaging to stage, re-stage and assess eligibility and response to therapy. 68Ga-DOTATATE is a nuclear medicine imaging agent that is not yet approved by Health Canada but used extensively throughout the world. The Ki-67 index, a marker of cell proliferation in NETs, is one of the most important prognostic factors in this disease. The objective of this study is to evaluate if the maximal standard uptake value (SUVmax) on PET/CT in NETs inversely correlates with Ki-67 score on initial biopsy. If this hypothesized correlation between SUV and Ki-67 score is reproduced, then DOTATATE would serve as a non-invasive method to assess cellular proliferation and therefore prognosis of these patients.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Known or suspected somatostatin receptor positive tumor such as: neuroendocrine tumor (carcinoid, gastro-entero-pancreatic neuroendocrine tumors, etc); pheochromocytoma; neuroblastoma; medulloblastoma; ectopic Cushing syndrome/non-pituitary ACTH elevation; tumor-induced osteomalacia. Supporting evidence may include MRI, CT, biochemical markers, and/or pathology report.
•Previous diagnosis of NET with Ki-67 index available or soon to be obtained.
•ECOG performance status 0 - 3, inclusive.
•18 years or older and able to understand and provide written informed consent
•Patients must be able to tolerate the physical/logistical requirements of a PET/CT scan including lying supine for up to 45 minutes with the arms above the head and tolerating intravenous cannulation for injection of the study drug

Exclusion Criteria

•Medically unstable patients (e.g. acute cardiac or respiratory distress or hypotensive, etc.)
•Patients who exceed the safe weight limit or bore of the PET/CT bed
•Patients who are claustrophobic or pregnant

Locations (1)

Jewish General Hospital

Montreal, Quebec, Canada

Key Dates

Start Date

October 1, 2019

Primary Completion Date

December 13, 2023

Completion Date

December 13, 2023

Last Updated

May 15, 2025

Enrollment

ACTUAL participants

Conditions

Neuroendocrine Tumors

Interventions

68Ga-DOTATATE PET/CT

DRUG

Lurbinectedin With or Without Avelumab in Small Cell Carcinoma of the Bladder (LASER)

NCT06228066

Small Cell Carcinoma of the BladderHigh Grade Neuroendocrine Tumors of the Urinary Tract

View study

RECRUITINGPHASE2

Lenvatinib Plus Pembrolizumab in Well Differentiated G3 Neuroendocrine Tumors

NCT05746208

Neuroendocrine TumorsWell-Differentiated Neuroendocrine Carcinoma+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

SUV on 68Ga-DOTATATE PET/CT and Ki-67 Index in Neuro-Endocrine Tumors

Inclusion Criteria

Exclusion Criteria

Lurbinectedin With or Without Avelumab in Small Cell Carcinoma of the Bladder (LASER)

Lenvatinib Plus Pembrolizumab in Well Differentiated G3 Neuroendocrine Tumors

A Study to Investigate Safety and Effectiveness of CRN09682 in Participants With SST2-Expressing NENs and Other Solid Tumors

F-Tryptophan PET/CT in Human Cancers

SVV-001 With Nivolumab and Ipilimumab in Patients With Poorly Differentiated Neuroendocrine Carcinomas (NEC) or Well-Differentiated High-Grade Neuroendocrine Tumors (NET)

A Study of BL-M14D1 in Patients With Locally Advanced or Metastatic Small Cell Lung Cancer, Neuroendocrine Tumors and Other Solid Tumors