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Double PET scan may unlock secrets of gut tumors

NCT ID NCT04804371

Knowledge-focused Sponsor: University Health Network, Toronto Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study is testing whether combining two different PET scans can give doctors a clearer picture of neuroendocrine tumors (NETs) in the gut. The scans measure how tumors take up different tracers, which may reveal whether a tumor is slow-growing or aggressive. The goal is to see if this information helps doctors choose the best treatment for each patient. The study involves 40 adults with well-differentiated G2-G3 GEP-NETs.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
F18-FDG (a radioactive tracer for PET scans)
What this could lead to
If successful, this could help doctors choose better treatments for patients with intermediate-grade neuroendocrine tumors by identifying which tumors are more aggressive.
What could go wrong
This is a small pilot study with only 40 participants, so results may not apply to everyone. It is designed to gather information, not to test a new treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2021

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Has provided written informed consent prior to any study-related procedures, 2. Is a male or a female of 18 years of age or older. 3. Patients who already had/scheduled for a 68Ga-DOTATATE PET/CT scan. 4. Has a gastro entero-pancreatic neuroendocrine neoplasm confirmed by histological criteria. Patients with unknown primaries clinically thought to be from gastroenteropancreatic source shall be eligible. 5. Has a well differentiated tumour Grade 2-3 (WHO 2017). 6. Has a tumour with a proliferation index (Ki67 ≥3%) or in samples where the Ki67 antigen cannot be reliably quantified, a mitotic index ≥2 mitosis/10HPF (high power fields) 7. Treatment naïve patients and/or patient who have received any number of prior systemic therapy lines for metastatic disease and/or locally advanced inoperable tumor. 8. Willing and able to comply with all study requirements, including timing and/or nature of required assessments. 9. Women of child-bearing age will undergo a urine test to exclude pregnancy prior to PET. Exclusion Criteria: 1. Patients with known lung neuroendocrine tumours or other proven non gastroenteropancreatic histologies are not eligible. 2. Patients with any known hypersensitivity to FDG. 3. Has a well differentiated neuroendocrine tumour Grade 1 (WHO 2017). 4. Has a poorly differentiated neuroendocrine carcinoma (WHO 2017). 5. Mixed neuroendocrine and non-neuroendocrine cancer 6. Has any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude. 7. Any patient who is pregnant.

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Conditions

The condition(s) this trial relates to.

digestive system neuroendocrine tumor, grade 1/2 neuroendocrine neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neuroendocrine tumors

Contacts and locations

Locations

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.