Neuroendocrine TumorsPhase 3NCT02840149
SUV on 68Ga-DOTATATE PET/CT and Ki-67 Index in Neuro-Endocrine Tumors
A Phase 3 study testing 68Ga-DOTATATE PET/CT in people with Neuroendocrine Tumors, run by Jewish General Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- 68Ga-DOTATATE PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2019to 13 Dec 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between SUV on 68Ga-DOTATATE PET/CT and Ki-67 Index in Neuro-Endocrine Tumors
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
- Being tested
- 68Ga-DOTATATE PET/CT
- Keywords
- 68Ga-DOTA-TATE, PET/CT
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-DOTATATE PET/CTDrug
68Ga-DOTATATE PET/CT scan
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-DOTATATE PET/CT | Other | 68Ga-DOTATATE PET/CT scan performed on Neuro-endocrine tumor patients Receives: Drug: 68Ga-DOTATATE PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study start1 Oct 2019
- Primary completion13 Dec 2023
- Study completion13 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jewish General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gad Abikhzer, Jewish General Hospital
- Investigators
- Gad Abikhzer, MDCM, Principal investigator, McGill University Health Centre, Jewish General HospitalStephan Probst, MDCM, Principal investigator, Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02840149
- Sponsor's protocol ID
- CODIM-MDM-16-211
- Status last verified
- Dec 2023
- First submitted
- 14 Jul 2016
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between SUV on 68Ga-DOTATATE PET/CT and Ki-67 Index in Neuro-Endocrine Tumors
- ClinicalTrials.gov ID
- NCT02840149
- Acronym / sponsor ID
- CODIM-MDM-16-211
- Conditions
- Neuroendocrine Tumors
- Keywords
- 68Ga-DOTA-TATE, PET/CT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Jewish General HospitalUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 13 Dec 2023 (actual)
- Study completion
- 13 Dec 2023 (actual)
- First posted
- 21 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-DOTATATE PET/CT | Other | Drug: 68Ga-DOTATATE PET/CT68Ga-DOTATATE PET/CT scan performed on Neuro-endocrine tumor patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-DOTATATE PET/CT68Ga-DOTATATE PET/CT scan | Drug | 68Ga-DOTATATE PET/CT |
Primary outcome
Correlation between SUV on 68Ga-DOTATATE PET/CT with Ki-67 index in NET
Time frame: 2 years
To determine whether there is an inverse correlation between SUV on 68Ga-DOTATATE PET/CT with Ki-67 index in patients with neuroendocrine tumors
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gad Abikhzer, MDCM principal investigator
McGill University Health Centre, Jewish General Hospital
Stephan Probst, MDCM principal investigator
Jewish General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 68Ga-DOTATATE PET/CT in people with Neuroendocrine Tumors, run by Jewish General Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between SUV on 68Ga-DOTATATE PET/CT with Ki-67 index in NET (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.