CraniopharyngiomaNCT07177482
ImmunoPET Targeting Trophoblast Cell-surface Antigen 2 (Trop-2) in Craniopharyngioma Patients
A study testing 68Ga-MY6349 PET/CT in people with Craniopharyngioma, run by Deling Li at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 to 80 years
- Conditions the study is for
- Craniopharyngioma
- What is being tested?
- 68Ga-MY6349 PET/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 4 Jul 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100070
Deling Li, MD, +86 13810098236, lideling@bjtth.org
About this study
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.
Read the detailed description
The trophoblast cell surface antigen 2 (Trop2), encoded by the TACSTD2 gene, is a transmembrane glycoprotein that regulates epithelial malignant transformation and proliferation. Trop2 has been reported to be overexpressed in various epithelial tumors, including craniopharyngioma. 68Ga-MY6349, an immune-PET tracer targeting Trop2, has demonstrated high specificity and sensitivity in visualizing other Trop2-high solid tumors. In this research, patients with primary or recurrent craniopharyngioma scheduled for surgery will receive the preoperative 68Ga-MY6349 PET/CT in addition to standard MRI. Tumor uptake is quantified by the maximum standardized uptake value (SUVmax). The diagnostic performance of 68Ga-MY6349 PET is subsequently compared with MRI and the SUVmax is correlated with Trop2 expression levels in postoperative pathological specimens.
- Conditions
- Craniopharyngioma
- Being tested
- 68Ga-MY6349 PET/CT
- Keywords
- Positron-Emission Tomography, Diagnosis
- Medical subject headings
- Craniopharyngioma, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-MY6349 PET/CTDiagnostic test
Each subject receives a single intravenous injection of 68Ga-MY6349 and undergoes PET/CT imaging within the specified time.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-MY6349 PET/CT | Experimental | Each subject receives a single intravenous injection of 68Ga-MY6349 and undergoes PET/CT imaging within the specified time. Receives: Diagnostic Test: 68Ga-MY6349 PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Within 2 week after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start4 Jul 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CraniopharyngiomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deling Li
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College Hospital
- Responsible party
- Sponsor-investigator, Deling Li, Beijing Tiantan Hospital
- Investigators
- Deling Li, MD, Study chair, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07177482
- Sponsor's protocol ID
- BTHospital-N-010
- Status last verified
- Sep 2025
- First submitted
- 10 Sep 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ImmunoPET Targeting Trophoblast Cell-surface Antigen 2 (Trop-2) in Craniopharyngioma Patients
- ClinicalTrials.gov ID
- NCT07177482
- Acronym / sponsor ID
- BTHospital-N-010
- Conditions
- Craniopharyngioma
- Keywords
- Positron-Emission Tomography, Diagnosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Deling LiUniversity, hospital or other
- Collaborators
- Peking Union Medical College Hospital
- Study start
- 4 Jul 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The trophoblast cell surface antigen 2 (Trop2), encoded by the TACSTD2 gene, is a transmembrane glycoprotein that regulates epithelial malignant transformation and proliferation. Trop2 has been reported to be overexpressed in various epithelial tumors, including craniopharyngioma. 68Ga-MY6349, an immune-PET tracer targeting Trop2, has demonstrated high specificity and sensitivity in visualizing other Trop2-high solid tumors. In this research, patients with primary or recurrent craniopharyngioma scheduled for surgery will receive the preoperative 68Ga-MY6349 PET/CT in addition to standard MRI. Tumor uptake is quantified by the maximum standardized uptake value (SUVmax). The diagnostic performance of 68Ga-MY6349 PET is subsequently compared with MRI and the SUVmax is correlated with Trop2 expression levels in postoperative pathological specimens.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-MY6349 PET/CT | Experimental | Diagnostic Test: 68Ga-MY6349 PET/CTEach subject receives a single intravenous injection of 68Ga-MY6349 and undergoes PET/CT imaging within the specified time. |
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-MY6349 PET/CTEach subject receives a single intravenous injection of 68Ga-MY6349 and undergoes PET/CT imaging within the specified time. | Diagnostic test | 68Ga-MY6349 PET/CT |
Primary outcome
Standardized uptake value of 68Ga-MY6349 in PET imaging of craniopharyngioma
Time frame: Within 1 week after PET imaging.
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.
1 secondary outcome
Evaluate the feasibility of PET/CT imaging with 68Ga-MY6349 for the non-invasive assessment of Trop2 expression in craniopharyngioma.
Time frame: Within 2 week after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Deling Li, MD study chair
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 68Ga-MY6349 PET/CT in people with Craniopharyngioma, run by Deling Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Deling Li, MD (+86 13810098236, lideling@bjtth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized uptake value of 68Ga-MY6349 in PET imaging of craniopharyngioma (time frame: Within 1 week after PET imaging.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.