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New scan could spot cancer marker better than current tests

NCT ID NCT06369831

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests a new type of PET/CT scan that uses a radioactive tracer called 68Ga-ABS011 to detect HER2, a protein found on some cancer cells. The goal is to see if this scan can more accurately determine HER2 status in people with metastatic breast cancer or other solid tumors that have spread. Researchers will compare the scan results with standard biopsy and imaging methods. The study involves 60 adults and aims to improve how doctors choose the right treatments for each patient.

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 60 people

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

Started

Sep 2024

Expected to finish

Sep 2026

An estimate. End dates often move.

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. Adult (≥ 18 years at the time of informed consent signature) male or female patient 2. Patient with confirmed de novo or pre-treated metastatic solid tumors (multiple previous treatment lines in metastatic setting are allowed). 2.1. Patients with documented hormone receptor positive/HER2 negative, triple-negative or HER2 positive mBC that could become eligible for commercially available HER2 targeted monotherapy (i.e. through confirmation of HER2 IHC non-0 status assessed during the course of the study) or 2.2 Other metastatic solid tumors, not necessarily eligible for commercially available HER2 targeted monotherapy . 3. Patient presenting with at least one target biopsiable, FDG positive , non-liver metastatic lesion of ≥15 mm defined on ceCT (as part of screening 18F-FDG PET/ceCT assessment). 4. Patient willing to undergo at least one tumor biopsy. 5. Male patients able to father children and female patients of childbearing potential agree to use effective methods of contraception during the diagnostic and SOCa treatment follow-up study phases. 6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 7. Ability and willingness of the research participant to provide written informed consent. Exclusion Criteria: 1. Primary (non-metastatic) solid tumor cancer. 2. Patient not willing to undergo at least one tumor biopsy. Note: A recent biopsy and accompanied locally assessed IHC/ISH analyses, completed before screening, will not be accepted for study purposes. 3. 18F-FDG PET/ceCT completed before screening and patient not willing to repeat this assessment. 4. Metastatic setting 18F-FDG PET/ceCT indicating that the identified tumor lesions cannot be biopsied due their location and/or tissue type and/or an increased risk for serious comorbidities. 5. Brain and liver metastases are the sole sites of metastatic disease. 6. Life expectancy lower than 3 months. 7. Pregnancy or breastfeeding. 8. Inadequate organ function, suggested by clinically relevant abnormal laboratory results: 1. Significantly impaired renal function defined as estimated Glomerular Filtration Rate (GFR) \<30 ml/min/1.73m2. 2. Absolute neutrophil count \<1,500 cells/mm3. 3. Total bilirubin \~1.5 x Upper Limit of Normal (ULN) (unless the patient has documented Gilbert's syndrome). 4. Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or Alanine aminotransferase (ALT)/ serum glutamic pyruvic transaminase (SGPT) \>5.0 x ULN. 9. Patients with a known hypersensitivity to any of the investigational medicinal product (IMP) components or packaging. 10. Patients with increased risks of bleeding or other complications from biopsies (e.g. patients under anticoagulation therapy for whom temporary discontinuation of this therapy cannot be safely performed). 11. Patients with a known hypersensitivity or contraindication for iodinated contrast media (iCM) which cannot be controlled by taking prophylactic measures (e.g. temporary treatment interruption or introduction of adequate pre-medication). 12. Patients who cannot undergo PET/CT scanning (including but not limited to body size and claustrophobia). 13. Any condition that in the opinion of the investigator may significantly interfere with study compliance (including but not limited to psychological or psychiatric, social or geographical condition potentially hampering compliance with the study requirements).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    6 sites in 2 countries. 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

  • AZ Delta CHIREC

    RECRUITING

    Brussels, Brussels Capital, 1070, Belgium

  • Cliniques Universitaires Saint-Luc

    RECRUITING

    Brussels, Brussels Capital, 1070, Belgium

  • Free University Brussels (VUB)

    RECRUITING

    Brussels, Brussels Capital, 1070, Belgium

  • Institut Jules Bordet

    RECRUITING

    Brussels, Brussels Capital, 1070, Belgium

  • Medizinische Universität Innsbruck

    RECRUITING

    Innsbruck, Tyrol, A-6020, Austria

  • OLV Aalst

    COMPLETED

    Aalst, East-Flanders, 9300, Belgium

  • University Hospital Gasthuisberg

    RECRUITING

    Leuven, Belgium

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