Cure My Disease

Don't miss your cure!

 Log in / Sign up

New PET scan tracer could sharpen view of melanoma treatment response

NCT ID NCT07215182

Diagnosis Sponsor: Barbara Malene Fischer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 2 trial is testing whether a new radioactive tracer, [68Ga]Ga-FAPI-46, can improve how doctors evaluate response to immunotherapy in patients with stage IV melanoma. Twenty participants will receive two experimental PET/CT scans—one before starting immunotherapy and one after three months—along with blood samples. The results will be compared with standard FDG PET/CT scans to see if the new tracer provides clearer information about tumor changes.

What this could mean

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

Active substance
[68Ga]Ga-FAPI-46 (an experimental imaging tracer)
What this could lead to
If successful, this could provide a more accurate way to measure how well immunotherapy is working in advanced melanoma patients, potentially guiding treatment decisions.
What could go wrong
This is a small, early-phase study (20 participants) focused on imaging, not treatment. The tracer may not prove more useful than current standard scans, and results may not apply to all patients.

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

About 20 people

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

Started

Aug 2025

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. Male or female, \>/=18 years old 2. Histological verified metastatic or locally advanced malignant melanoma 3. Visible malignant lesions on \[18F\]FDG PET/CT or CT 4. Subjects must be considered inoperable 5. Subjects must be considered medically suitable for ICT 6. Subjects must be able to read and understand the patient information in Danish to give informed consent Exclusion Criteria: 1. Ocular or mucosal melanoma 2. Other concurrent cancer disease 3. Previous systemic oncological treatment with ICT 4. Pregnancy or lactation 5. Weight more than the maximum limit of a PET/CT-scanner bed (140 kg) 6. History of allergic reaction due to compounds similar to the chemical composition of \[68Ga\]Ga-FAPI- 46

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Malignant melanoma stage IV are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

melanoma metastatic melanoma

As listed by the trial registrant

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

Malignant melanoma stage IV

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Herlev Universityhospital

    RECRUITING

    Herlev, Capital Region, 2730, Denmark

  • Rigshospitalet

    RECRUITING

    Copenhagen, Ca, 2100, Denmark

More trials for these conditions

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