ImmunoPET Targeting Trophoblast Cell-surface Antigen 2 (Trop-2) in Craniopharyngioma Patients
ConditionCraniopharyngioma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-80
SponsorDeling Li
About this trial
This study aims to investigate 68Ga-MY6349, an immune-PET tracer targeting trophoblast cell surface antigen 2 (Trop2), for the noninvasive diagnosis of craniopharyngioma in vivo.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
68Ga-MY6349 PET/CT
Diagnostic testEach subject receives a single intravenous injection of 68Ga-MY6349 and undergoes PET/CT imaging within the specified time.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: 68Ga-MY6349 PET/CTExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Standardized uptake value of 68Ga-MY6349 in PET imaging of craniopharyngioma
The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in craniopharyngioma will be measured.
Time frame
Within 1 week after PET imaging.Secondary outcomes
1
Evaluate the feasibility of PET/CT imaging with 68Ga-MY6349 for the non-invasive assessment of Trop2 expression in craniopharyngioma.
Trop2 expression analysis in tumor sample will be correlated to 68Ga-MY6349 tumor uptake, evaluated by measuring standardized uptake value (SUV) on the 68Ga-MY6349 PET/CT.
Time frame
Within 2 week after surgery.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Deling Li
Lead sponsor
Beijing Tiantan Hospital
Sponsor institution
Peking Union Medical College Hospital
Collaborator
Source ClinicalTrials.gov