New imaging agent aims to sharpen cancer detection
NCT ID NCT07707999
First seen Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time
Summary
This early-phase study tests a new radioactive imaging probe that targets a protein called FAP, found on many solid tumors. The probe is used with PET or SPECT scans to see if it can better locate tumors and determine if they have spread, compared to standard FDG-PET imaging. The trial involves 20 adults with confirmed or suspected solid tumors, and aims to evaluate the probe's diagnostic accuracy, safety, and how it distributes in the body.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a novel FAP-targeted radioactive imaging probe (68Ga-FAP or 177Lu-FAP)
- What this could lead to
- If successful, this imaging method could help doctors more accurately detect and stage solid tumors, potentially guiding better treatment decisions.
- What could go wrong
- This is a very early, small study (20 people) focused on imaging accuracy, not treatment. The new probe may not prove more effective than current standard imaging.
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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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
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 years and older
- 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. Voluntary participation and the patient or their legal representative is able to sign an informed consent form. 2. Adult patients (aged 18 or above), regardless of gender. 3. Patients with an ECOG performance status of 0 to 1 and able to tolerate PET and SPECT/CT examinations. 4. Patients with histopathologically or clinically confirmed malignant solid tumors who have measurable lesions according to RECIST 1.1 criteria. 5. Patients with expected survival\>6 months. 6. Female patients of childbearing potential must have a negative pregnancy test, and all patients (including male patients) agree to use effective contraceptive measures during the study period and for at least three months after study drug administration. Exclusion Criteria: 1. Patients who are pregnant or breastfeeding, or plan to become pregnant during the study period or within three months after study drug administration (excluding those who have been postmenopausal for at least one year, or those who are surgically sterilized, such as bilateral tubal ligation without recanalization, bilateral oophorectomy, or hysterectomy); or patients who plan to donate sperm or eggs during the study period or within three months after study drug administration. 2. Patients with known or suspected allergy to the investigational drug or any of its components, or patients with severe allergic constitution. 3. Patients who have undergone procedures within 6 months prior to study entry that, in the investigator's judgment, may affect drug absorption, distribution, metabolism, or excretion. 4. Patients with positive syphilis or HIV test results at screening. 5. Patients with abnormal liver or kidney function: serum total bilirubin (TBIL) \> 31.5 umol/L; aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 120 U/L, or \> 200 U/L if the elevation is considered to be related to liver metastases from solid tumors; serum creatinine (Scr) \> 150 umol/L, or creatinine clearance \< 60 mL/min (according to the Cockcroft-Gault formula). 6. Patients with abnormal bone marrow parameters: absolute neutrophil count \< 1.5 x 10\^9/L, hemoglobin \< 10 g/dL, serum albumin \< 2.8 g/dL (normal range 3.5-5.5 g/dL), platelets \< 100 x 10\^9/L (normal range 100-300 x 10\^9/L), international normalized ratio (INR) \> 1.5 (normal range 0.8-1.3) in patients not taking warfarin, or prothrombin time (PT) \> 2 x ULN (normal range 11-15 seconds). 7. Patients with active infection (e.g., acute bacterial infection, tuberculosis, active hepatitis B/C, active syphilis, etc.). Active hepatitis B is defined as: positive HBsAg or HBcAb, or results outside the normal reference range, accompanied by hepatitis B virus DNA titer \> 2500 copies/mL or \> 500 IU/mL. Active hepatitis C is defined as: positive hepatitis C antibody, or results outside the normal reference range, and positive HCV-RNA. 8. Patients with dysuria or urinary incontinence due to any cause. 9. Patients with claustrophobia or other conditions that preclude cooperation with PET/MR and SPECT/CT examinations. 10. Patients with psychiatric disorders such as depressive symptoms, schizophrenia, delusions, hallucinations, or suicidal ideation. 11. Patients with severe cardiovascular disease, including but not limited to New York Heart Association (NYHA) class II to IV congestive heart failure, or left ventricular ejection fraction (LVEF) \< 50% or below the lower limit of normal. 12. Patients with other conditions that, in the investigator's opinion, make the patient unsuitable for participation in this study.
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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
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.
Contacts and locations
Locations
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Wuhan union hosptital
Wuhan, Hubei, China
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