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PET scan study hints at new hope for tough gut cancer

NCT ID NCT04069299

Knowledge-focused Sponsor: H. Lee Moffitt Cancer Center and Research Institute 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at 30 adults with a rare, fast-growing type of gut cancer called poorly differentiated neuroendocrine carcinoma. Researchers used a special PET scan (68Ga-DOTATATE) to measure how much of a protein called somatostatin receptor is present on tumors. The goal was to see if enough patients have this protein to make a future treatment called PRRT (peptide receptor radiotherapy) worth testing. The study is complete and provides important information for designing future treatment trials.

What this could mean

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

Active substance
68Ga-DOTATATE (a radioactive tracer used in PET scans)
What this could lead to
If successful, this could show whether a targeted radiation therapy (PRRT) might work for patients with this aggressive cancer.
What could go wrong
This is a small, completed imaging study (30 people) that only measures receptor levels—it does not test treatment itself, so any therapy benefit remains uncertain.

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.

Participants

30 people

The number who actually took part.

Started

Sep 2019

Finished

Jun 2025

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.

Who is studied

Patients of Moffitt Cancer Center's GI Clinic

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: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female ≥ 18 years old * Histologically confirmed diagnosis of poorly-differentiated neuroendocrine carcinoma of the gastroenteropancreatic tract or unknown primary * Evidence of measurable disease per RECIST 1.1 on another imagine modality (CT, MRI or FDGPET) with at least 3 tumors \>1cm in largest diameter. CT, MRI or Fluorodeoxyglucose (FDG)-PET must have been performed within 2 months of the study scan. (Of note, participants may sign consent for the study prior to scheduling of said CT, MRI or FDG-PET, but will be considered screen failures if the CT/MRI/FDG-PET does not reveal at least 3 tumors \>1cm). Exclusion Criteria: * Participants with well-differentiated neuroendocrine tumors * Participants who have undergone 68Ga-dotatate PET scan in the past * Pregnant women and/or breastfeeding women. Women of child bearing potential must have a negative pregnancy test prior to scan.

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Conditions

The condition(s) this trial relates to.

digestive system neuroendocrine neoplasm neuroendocrine carcinoma

As listed by the trial registrant

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

Neuroendocrine; carcinoma

Contacts and locations

Locations

  • H Lee Moffitt Cancer & Research Institute

    Tampa, Florida, 33612, United States

More trials for these conditions

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