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New PET tracer may reveal hidden cancer targets

NCT ID NCT07577206

Diagnosis Sponsor: National Cancer Institute, Naples 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-stage study tests a single dose of a new radioactive tracer called [68Ga]Ga-R54, which attaches to a protein (CXCR4) found on some cancer cells. Ten adults with advanced solid tumors or multiple myeloma will receive the tracer and then have a PET/CT scan to see where it goes in the body. The goal is to measure how well the tracer binds to tumors and how it moves through the blood, which could help improve cancer imaging in the future.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 10 people

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

Started

Jan 2025

Expected to finish

Jan 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: * Patients \> 18 years * Patients with histological diagnosis of solid neoplasm (breast, lung, colon, ovary, pancreas) in advanced stages or multiple myeloma evaluated by PET/CT with \[18F\]FDG carried out in the 3 months prior to enrollment. The neoplasm must express the CXCR4 receptor by immunohistochemistry * Patients with ECOG performance status 0-2, able to undergo the scheduled diagnostic procedure (PET/CT with \[68Ga\]Ga-R54). * Patients with alkaline phosphatase (AP), alanine aminotransferase (ALT), and aspartate aminotransferase \<3 x upper limit of reference range and total bilirubin \<2.0 mg/dL * Patients with creatinine \< 1.5 x upper limit of reference range or 24-hour creatinine clearance \> 50 mL/min * Negative serum pregnancy test (b-hCG) for women of childbearing age before administration of \[68Ga\]Ga-R54). * Signature of informed consent indicating that the patient (or legal representative) has been informed of all aspects pertinent to the study * Willingness and ability to comply with scheduled visits, laboratory tests and other study procedures. Exclusion Criteria: * Presence of active infections (e.g. requiring antibiotic therapy) or other serious concomitant illness, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study * Declared chronic active hepatitis (hepatitis B / C) * Declared active autoimmune diseases * Recovery from major trauma including surgery within 4 weeks of study enrollment * Presence of neurodegenerative diseases * Pregnancy and/or breastfeeding * Any conditions that in the opinion of the investigator could hinder compliance with the study protocol * Patients who have not signed consent to participate in the study

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Conditions

The condition(s) this trial relates to.

neoplasm plasma cell myeloma

As listed by the trial registrant

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

Advanced solid tumor Multiple myeloma

How to take part

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

  1. The places running it

    1 site. 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

  • Istituto Nazionale Tumori Fondazione G. Pascale - SC Medicina Nucleare e Terapia Metabolica

    RECRUITING

    Naples, Italia, 80131, Italy

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