New radioactive tracers could spot cancers more clearly
NCT ID NCT07639970
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
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 90 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
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