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

NCT02840149 | Completed Phase 3

• 1 other identifier: CODIM-MDM-16-211
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neuroendocrine Tumors

Keywords

68Ga-DOTA-TATE, PET/CT

Outcome Measures

Primary Outcomes (1)

• Correlation between SUV on 68Ga-DOTATATE PET/CT with Ki-67 index in NET

  To determine whether there is an inverse correlation between SUV on 68Ga-DOTATATE PET/CT with Ki-67 index in patients with neuroendocrine tumors

  2 years

Study Arms (1)

68Ga-DOTATATE PET/CT

OTHER

68Ga-DOTATATE PET/CT scan performed on Neuro-endocrine tumor patients

Drug: 68Ga-DOTATATE PET/CT

Interventions

68Ga-DOTATATE PET/CT DRUG

68Ga-DOTATATE PET/CT scan

68Ga-DOTATATE PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jewish General Hospital: lead

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H4R3E8, Canada

Location

MeSH Terms

Conditions

Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Study Officials

• Gad Abikhzer, MDCM

  McGill University Health Centre, Jewish General Hospital

  PRINCIPAL INVESTIGATOR

• Stephan Probst, MDCM

  Jewish General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 14, 2016
• First Posted: July 21, 2016
• Study Start: October 1, 2019
• Primary Completion: December 13, 2023
• Study Completion: December 13, 2023
• Last Updated: May 15, 2025

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)