Radiation probe targets Hard-to-Treat tumors
NCT ID NCT07822347
First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time
Summary
Researchers are testing a new molecular probe called 177Lu-NI-FAPI that aims to deliver radiation directly to tumor cells. The probe targets two features common in aggressive tumors: low oxygen levels and fibroblast activation proteins. The study enrolls up to 20 adults with advanced tumors that have not responded to standard treatments, and it measures side effects and changes in tumor size and imaging.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a dual-target molecular probe called 177Lu-NI-FAPI that delivers radiation to tumor tissue
- What this could lead to
- If it works, this could offer a targeted radiation option for advanced tumors that have stopped responding to chemotherapy, radiotherapy, or other drugs.
- What could go wrong
- This is a small, early-stage study of 20 people with hard-to-treat tumors. The probe may not reach tumors effectively, may cause radiation-related side effects, or may not help patients live longer.
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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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Jul 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 80 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: * Age between 18-80 years old * Obtain pathological results through surgery or biopsy * Loss of surgical opportunity (distant metastasis, or unsuitability for surgery due to contraindications); The condition still progresses after conventional chemotherapy, radiotherapy, targeted drug therapy, and other treatments (according to RECIST/PERCAST criteria) * Expected survival time greater than 6 months * Baseline \[68Ga\] Ga-NI-FAPI-04 PET/CT imaging reveals high uptake lesions * Informed consent and the ability to accept follow-up * Bone marrow reserve: neutrophil count ≥ 1.5 × 109/L; platelet count ≥ 100 × 109/L; hemoglobin ≥ 90 g/L * Liver function: AST/ALT ≤ 3 × ULN, or subjects with liver metastasis\<5 × ULN; Albumin\>3.0 g/dL; Total bilirubin ≤ 1.5 × ULN * Renal function: creatinine clearance rate ≥ 50 mL/min * Coagulation function: INR ≤ 1.5 (for patients who have not received warfarin treatment); Prothrombin time (PTT)\<2 × ULN Exclusion Criteria: * Pregnant and lactating female patients * Individuals who fear confinement or radiation * Individuals who have received systemic anti-tumor treatment, including chemotherapy or curative radiotherapy, within 4 weeks prior to their first medication, or who have received TKI treatment within 2 weeks * Patients treated with isotopes such as strontium-89, samarium-153, rhenium 186, rhenium 188, radium-223, etc. within 6 months * Individuals who have experienced severe allergic reactions to the components of \[177Lu\] Lu-NI-FAPI-04 injection in the past * Received any investigational medication within 28 days prior to the first dose, or participated in another clinical study at the same time (except for those who participated in observational, non interventional clinical studies, or are currently in the follow-up period of interventional clinical studies) * Patients who are difficult to receive further diagnosis and treatment due to severe illness
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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 places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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.
Contacts and locations
Locations
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Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, Beijing Municipality, China
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