Trop‑2 PET imaging for craniopharyngioma diagnosis
Official title: ImmunoPET Targeting Trophoblast Cell-surface Antigen 2 (Trop-2) in Craniopharyngioma Patients
Run by Beijing Tiantan Hospital · NCT07177482 · Data updated 2026-11-12
This will test whether a Trop‑2–targeting PET tracer (68Ga‑MY6349) can help diagnose craniopharyngioma in people scheduled for surgical removal.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 14 Years to 80 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | July 4, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | September 17, 2025 |
| Trial ID | NCT07177482 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with radiologically presumed or histologically confirmed craniopharyngioma (primary or recurrent) who are scheduled for resection, can give written informed consent, and have a Karnofsky performance status ≥70 are ideal candidates.
✕Probably not a fit
Patients with severe hepatic or renal dysfunction, major concurrent CNS disorders, severe allergy to IV contrast, claustrophobia preventing imaging, or who are pregnant or breastfeeding are excluded and likely will not benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Patients with primary or recurrent craniopharyngioma who are scheduled for surgery will receive a preoperative 68Ga‑MY6349 PET/CT in addition to standard MRI. Tumor uptake on PET will be quantified using maximum standardized uptake value (SUVmax). PET diagnostic performance will be compared with MRI findings, and PET uptake (SUVmax) will be correlated with Trop‑2 expression measured in the postoperative pathology specimens. The protocol is designed to determine whether Trop‑2 immuno‑PET can noninvasively identify Trop‑2–expressing craniopharyngiomas and improve lesion visualization prior to resection.
Why it matters
Potential benefit: If successful, this imaging approach could provide a noninvasive way to identify and better localize Trop‑2–expressing craniopharyngiomas before surgery, potentially improving surgical planning.
How similar studies have gone: Trop‑2–targeted immuno‑PET tracers including 68Ga‑MY6349 have shown high specificity and sensitivity in other Trop‑2–high solid tumors, but application specifically to craniopharyngioma is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria: * must be able to provide a written informed consent * radiologically presumed and/or histologically confirmed craniopharyngioma scheduled for resection * adequate clinical condition (Karnofsky performance status ≥70) Exclusion criteria: * concomitant major central nervous system disorders * severe hepatic or renal dysfunction * history of severe allergy or hypersensitivity to intravenous radiographic contrast agents * claustrophobia precluding PET/CT or MRI examinations * pregnancy or breastfeeding
Where it's running
-
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: Deling Li, MD
- Email: lideling@bjtth.org
- Phone: +86 13810098236
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.