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

NCT ID: NCT02840149

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2023-12-13

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

68Ga-DOTATATE PET/CT

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

Group Type: OTHER

68Ga-DOTATATE PET/CT

Intervention Type: DRUG

68Ga-DOTATATE PET/CT scan

Interventions

68Ga-DOTATATE PET/CT

68Ga-DOTATATE PET/CT scan

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jewish General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Gad Abikhzer

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gad Abikhzer, MDCM

Role: PRINCIPAL_INVESTIGATOR

McGill University Health Centre, Jewish General Hospital

Stephan Probst, MDCM

Role: PRINCIPAL_INVESTIGATOR

Jewish General Hospital

Locations

Jewish General Hospital

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

CODIM-MDM-16-211

Identifier Type: -

Identifier Source: org_study_id