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

Study Overview
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Brief Summary
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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.

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

Conditions
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Neuroendocrine Tumors

Intervention / Treatment
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* Drug: 68Ga-DOTATATE PET/CT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 68Ga-DOTATATE PET/CT<br>68Ga-DOTATATE PET/CT scan performed on Neuro-endocrine tumor patients | Drug: 68Ga-DOTATATE PET/CT<br>* 68Ga-DOTATATE PET/CT scan<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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68Ga-DOTA-TATE, PET/CT