New PET tracer aims to light up hidden cancer targets

NCT ID NCT07828678

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Registered, but not yet taking participants.
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Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
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Running, but no longer taking on new participants.
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The trial has finished. Results may not be published yet.
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Cancelled before anyone took part.

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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First seen Sep 18, 2026 · Last updated Sep 18, 2026

Summary

Researchers are testing a new PET/CT imaging tracer called [68Ga]-LY4257529 that targets a protein called GRPR, which some cancers make in large amounts. The study includes up to 60 adults with breast cancer or other tumors known or suspected to express GRPR, such as prostate, ovarian, pancreatic, small-cell lung, and head and neck cancers. Participants receive one intravenous dose of the tracer, then undergo a PET/CT scan about an hour later to see whether the tracer highlights GRPR-positive tumors. The main goal is to measure how often the scan detects at least one GRPR-positive lesion in each cancer group.

What this could mean

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

Active substance
an investigational GRPR-targeted PET imaging tracer called [68Ga]-LY4257529
What this could lead to
If it works, this imaging approach could give doctors a new way to see which tumors carry GRPR, helping guide treatment decisions for breast, prostate, ovarian, pancreatic, lung, and head and neck cancers.
What could go wrong
This is an early-phase study with 60 participants, so it cannot prove the tracer improves patient outcomes. The tracer may not detect tumors reliably, and PET imaging carries small radiation exposure risks.

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 60 people

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

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Jun 2029

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: Age 18 years or older Able to understand and provide written informed consent Diagnosis of a breast cancer or other tumor known or suspected to express GRPR, including: ER-positive/HER2-negative breast cancer Invasive lobular breast cancer Head and neck squamous cell carcinoma Small-cell lung cancer Ovarian cancer Prostate cancer with biochemical recurrence and a negative PSMA PET/CT Metastatic pancreatic cancer after pancreatic surgery Other tumor with GRPR expression demonstrated on histopathology ECOG performance status 0-3 Under the care of a referring physician Able to tolerate PET/CT imaging, including lying supine for up to 30 minutes with arms above the head and intravenous cannulation Exclusion Criteria: Tumor type known in the literature not to express GRPR, unless patient-specific tissue demonstrates GRPR expression Medically unstable condition, including acute cardiac or respiratory distress or hypotension Weight exceeding PET/CT table limit of 200 kg or inability to fit within the 70-cm PET/CT bore Unmanageable claustrophobia Known allergic or hypersensitivity reaction to a prior GRPR-targeting radioligand such as ⁶⁸Ga-RM2 or bombesin analogues Pregnancy Lactation For individuals of childbearing potential, inability to document a negative pregnancy test before tracer administration

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Conditions

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