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Can a new PET tracer spot breast cancer spread better than standard scans?

NCT ID NCT05889728

Diagnosis Sponsor: St Vincent's Hospital, Sydney 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This trial is testing whether a new PET imaging agent called NeoB can more accurately detect the spread of a certain type of breast cancer (ER/PR positive, HER2 negative) compared to conventional scans like CT, bone scans, and FDG PET/CT. The study will enroll 20 women with metastatic breast cancer who need imaging to stage or restage their disease. Each participant will receive an injection of the NeoB tracer followed by a PET/CT scan, and the results will be compared to standard imaging and biopsy findings to assess diagnostic accuracy.

What this could mean

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

Active substance
A radioactive imaging agent called [68Ga]Ga-NeoB, given as an injection for PET/CT scans to detect breast cancer spread.
What this could lead to
If successful, this imaging method could improve the accuracy of staging metastatic breast cancer and help select patients for targeted radiation therapy.
What could go wrong
This is a small early-phase pilot study with only 20 participants, so results may not apply broadly. The imaging agent's accuracy and safety are still being evaluated.

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

20 people

The number who actually took part.

Started

Feb 2023

Finished

Feb 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.

Ages

18 years and older

Sex

Female participants only

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: * Female patients aged 18 or above * Ability to provide informed consent documentation indicating that they understand the purpose of and procedures required for the study, and are willing to participate in the study * Estrogen/Progesterone receptor +ve HER2 negative disease confirmed on prior biopsy (primary or metastatic site). * Metastatic breast cancer being staged or re-staged prior to treatment of metastatic disease (including those presenting with up-front metastatic disease with primary breast cancer in-situ and those who have progressed on a line of treatment for metastatic breast cancer that are suitable for another line of treatment) * Metastatic breast cancer being staged or restaged prior to change in treatment with standard imaging within 3 weeks of enrolment (CT CAP, bone scan, FDG PET CT) Exclusion Criteria: * Pregnancy or lactation (patients should use highly effective methods of contraception during and for 12h after administration) * Significant inter-current acute illness as per investigator discretion that prevent undertaking study procedures * History of current active malignancy as per investigator discretion other than breast cancer. * Known or expected hypersensitivity to 68Ga NeoB

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

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

Breast cancer

Contacts and locations

Locations

  • St Vincent's Hospital

    Sydney, New South Wales, 2010, Australia

More trials for these conditions

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