Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New imaging agent could sharpen pancreatic cancer detection

NCT ID NCT05262855

Diagnosis Sponsor: SOFIE 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a radioactive tracer called [68Ga]FAPI-46, used with a PET scan, to see if it can better detect pancreatic cancer cells. 63 adults with early-stage pancreatic cancer received the tracer before surgery. The goal was to see how well the scan matches the actual cancer found during surgery. If it works well, this could help doctors plan more precise surgeries.

What this could mean

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

Active substance
[68Ga]FAPI-46 (a radioactive tracer for PET imaging)
What this could lead to
If successful, this imaging method could help doctors more accurately detect and stage pancreatic cancer, leading to better surgical decisions.
What could go wrong
This is a small, early-phase study (63 participants) and the tracer is only for imaging, not treatment. It may not improve outcomes or be widely available.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

63 people

The number who actually took part.

Started

May 2022

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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. Pathologically confirmed pancreatic ductal adenocarcinoma 2. Treatment-naïve 3. Staged as resectable or borderline-resectable 4. Planned to undergo surgical resection or to receive neoadjuvant therapy (i.e., chemotherapy, radiation therapy, or combination) and subsequent possible surgical resection 5. Anatomic imaging (e.g., CT, MRI) obtained within ≤ 28 days of consent 6. Age ≥ 18 years 7. Completed informed consent as determined per the IRB of record Exclusion Criteria: 1. Pregnant as determined by a pregnancy test as per institutional guidelines for individuals of child-bearing potential 2. Declining to use effective contraceptive methods during the study (for individuals of child-producing potential) 3. Need for emergent surgery that would be delayed by participation 4. Bacterial, viral, or fungal infections requiring systemic therapy 5. Serious co-morbidities and serious nonmalignant disease (e.g., hydronephrosis, kidney failure, liver failure, systemic or local inflammatory or autoimmune diseases or other conditions) that in the opinion of the investigator, physician of record and/or Sofie could compromise patient safety and/or protocol objectives. 6. Known diagnosis of autoimmune disorders 7. Patients receiving any other investigational agent within the past 28 days 8. Breastfeeding. Note: nursing parents are allowed if the potential participant commits to pumping breast milk and discarding it from injection to ≥ 24 hours from the time of the \[68Ga\]FAPI-46 injection. 9. Known hypersensitivity to any excipients used in \[68Ga\]FAPI-46: trace amounts of sodium acetate sodium ascorbate and/or hydrochloric acid

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for FAP are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

classic familial adenomatous polyposis pancreatic ductal adenocarcinoma

As listed by the trial registrant

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

FAP Pdac - pancreatic ductal adenocarcinoma

Contacts and locations

Locations

  • BAMF Health

    Grand Rapids, Michigan, 49503, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • NYU Langone Health

    New York, New York, 10016, United States

  • University of California Los Angeles (UCLA) Health

    Los Angeles, California, 90095, United States

More trials for these conditions

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