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New radioactive tracers could spot cancers more clearly

NCT ID NCT07639970

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase study will test two radioactive tracers designed to light up certain solid tumors on scans. Twenty adults with breast, head and neck, pancreatic cancer, or glioma will receive an injection of the tracers and then undergo PET/CT and SPECT/CT imaging. The goal is to see if the tracers are safe and can help doctors see tumors more clearly.

What this could mean

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

Active substance
radioactive tracers (68Ga-HT547 and 177Lu-HT547)
What this could lead to
If successful, this could lead to a more accurate way to detect and monitor certain solid tumors using imaging scans.
What could go wrong
This is a very early, small study (20 people) focused on safety and imaging, not treatment. It may not lead to better outcomes for 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

Early phase 1

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

Participants

About 20 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Oct 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 to 90 years

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. Willing and able to communicate with the investigator, understand and comply with trial requirements, voluntarily participate in the trial, and provide written informed consent. 2. Aged 18 years or older, regardless of gender. 3. Expected survival of at least 3 months. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 5. Patients with solid tumors (breast cancer, head and neck cancer, pancreatic cancer, or brain glioma) confirmed by histology or cytology. 6. Radiographic evidence of disease progression within 12 months prior to screening (according to RECIST 1.1 criteria). 7. At least one measurable target lesion according to RECIST 1.1 criteria. 8. Positive uptake in the target lesion on ⁶⁸Ga-HT547 Positron Emission Tomography (PET) scan, with SUV ≥ 4. 9. Recovery from toxicities related to prior therapy to ≤ Grade 1 or baseline (except for alopecia, vitiligo, etc.). 10. For subjects of childbearing potential: Agreement to remain abstinent or use effective contraception (including intrauterine devices, etc.) from signing the ICF until at least 24 weeks after the last dose. Exclusion Criteria: 1. Pregnant or breastfeeding women, or women with a positive baseline pregnancy test. 2. History of severe allergic reaction to any component of the investigational drug injection. 3. Received blood transfusion within 4 weeks prior to screening to meet the enrollment criteria. 4. Received immunotherapy, chemotherapy, radiotherapy, or other anti-tumor therapy within 4 weeks prior to the first dose. 5. Received any investigational drug within 28 days prior to the first dose, or concurrent participation in another clinical study (except: participation in an observational, non-interventional study, or being in the follow-up phase of an interventional study). 6. History of other known malignancies within the past 5 years. 7. Presence of symptomatic or unstable third-space effusions (e.g., pleural effusion, ascites, pericardial effusion) requiring repeated drainage. 8. Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy. 9. Inadequate organ function (meeting any of the following): 1. Bone marrow reserve: Neutrophil count \< 1.5 x 10⁹/L, or platelet count \< 100 x 10⁹/L, or hemoglobin \< 90 g/L. 2. Liver function: AST/ALT \> 3 x ULN (\> 5 x ULN for subjects with liver metastases), or albumin ≤ 2.8 g/dL, or total bilirubin \> 1.5 x ULN. 3. Renal function: Serum creatinine \> 1.5 x ULN and creatinine clearance \< 60 mL/min (calculated by Cockcroft-Gault formula). 10. Severe cardiovascular clinical diseases or symptoms that may increase subject safety risk, including: 1. Congestive heart failure (New York Heart Association \[NYHA\] class \> II) within the past year. 2. Unstable angina within the past year. 3. Myocardial infarction within the past year. 4. Clinically significant malignant arrhythmia (except for atrial fibrillation, paroxysmal supraventricular tachycardia). 5. Presence of clinically significant QTcF prolongation (QTcF \> 470 ms, calculated by Fridericia's formula). 11. Clinically significant bleeding (e.g., gastrointestinal bleeding, intracranial hemorrhage) within 14 days prior to the first dose. 12. Major surgery or significant trauma within 28 days prior to the first dose. 13. Any other condition that, in the investigator's judgment, may increase safety risk or interfere with its interpretation. 14. Inability of the subject to understand and comply with study instructions and requirements. 15. Any other situation deemed inappropriate by the investigator.

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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

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  1. 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 ↗

  2. A doctor treating you

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