Trop‑2 PET imaging for craniopharyngioma diagnosis

ImmunoPET Targeting Trophoblast Cell-surface Antigen 2 (Trop-2) in Craniopharyngioma Patients

This will test whether a Trop‑2–targeting PET tracer (68Ga‑MY6349) can help diagnose craniopharyngioma in people scheduled for surgical removal.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 14 Years to 80 Years
• Sex: All
• Sponsor: Beijing Tiantan Hospital (other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07177482 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Beijing, Beijing Municipality

• Beijing Tiantan Hospital — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Deling Li, MD

Conditions: Craniopharyngioma, Positron-Emission Tomography, Diagnosis