Back to resultsSUV on 68Ga-DOTATATE PET/CT and Ki-67 Index in Neuro-Endocrine Tumors
Primary Purpose
Neuroendocrine Tumors
Status
Unknown status
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
68Ga-DOTATATE PET/CT
Sponsored by
About this trial
This is an interventional basic science trial for Neuroendocrine Tumors focused on measuring 68Ga-DOTA-TATE, PET/CT
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
Sites / Locations
- Jewish General Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
68Ga-DOTATATE PET/CT
Arm Description
68Ga-DOTATATE PET/CT scan performed on Neuro-endocrine tumor patients
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02840149
First Posted
July 14, 2016
Last Updated
February 8, 2021
Sponsor
Jewish General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02840149
Brief Title
SUV on 68Ga-DOTATATE PET/CT and Ki-67 Index in Neuro-Endocrine Tumors
Official Title
Correlation Between SUV on 68Ga-DOTATATE PET/CT and Ki-67 Index in Neuro-Endocrine Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jewish General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Tumors
Keywords
68Ga-DOTA-TATE, PET/CT
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
68Ga-DOTATATE PET/CT
Arm Type
Other
Arm Description
68Ga-DOTATATE PET/CT scan performed on Neuro-endocrine tumor patients
Intervention Type
Drug
Intervention Name(s)
68Ga-DOTATATE PET/CT
Intervention Description
68Ga-DOTATATE PET/CT scan
Primary Outcome Measure Information:
Title
Correlation between SUV on 68Ga-DOTATATE PET/CT with Ki-67 index in NET
Description
To determine whether there is an inverse correlation between SUV on 68Ga-DOTATATE PET/CT with Ki-67 index in patients with neuroendocrine tumors
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gad Abikhzer, MDCM
Organizational Affiliation
McGill University Health Centre, Jewish General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephan Probst, MDCM
Organizational Affiliation
Jewish General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jewish General Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4R3E8
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
SUV on 68Ga-DOTATATE PET/CT and Ki-67 Index in Neuro-Endocrine Tumors
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