ImmunoPET Targeting Trophoblast Cell-Surface Antigen 2 (Trop-2) in Thyroid Cancer (NCT06465017) | Clinical Trial Compass
TerminatedNot Applicable
ImmunoPET Targeting Trophoblast Cell-Surface Antigen 2 (Trop-2) in Thyroid Cancer
Stopped: The study was completed as planned after achieving the target enrollment and completing all protocol-specified procedures and follow-up.
China149 participantsStarted 2024-06-13
Plain-language summary
In this study, we comprehensively evaluated the clinical utility of Trop2 PET/CT (68Ga-MY6349 PET/CT) imaging for detecting recurrent and metastatic thyroid cancer, and the results were compared with those of 18F-FDG PET/CT. The primary objective of this study was to evaluate the patient-based sensitivity of 68Ga-MY6349 PET/CT in detecting recurrent and metastatic thyroid cancer. The secondary objectives included its overall specificity, lesion-based diagnostic performance, comparative tumor uptake relative to 18F-FDG PET/CT, safety profile, and the impact on clinical management.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult patients (aged 18 years or older);
* Patients with a history of previously treated thyroid cancer, including DTC and HGFCTC following thyroidectomy with or without 131I therapy, MTC after thyroidectomy, or ATC; either (1) evidence of structural or suspicious lesions on standard of care imaging or (2) biochemical evidence of disease in the absence of structural findings, defined as elevated thyrotropin suppressed thyroglobulin (Tgon ≥1 ng/mL after 131I ablation or ≥5 ng/mL without ablation) with negative anti thyroglobulin antibodies (\<20 IU/mL) for DTC and HGFCTC or elevated calcitonin (\>10 pg/mL) for MTC;
* Patients who had scheduled both standard-of-care imaging (18F-FDG PET/CT) and 68Ga-MY6349 scans;
* Patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.
* No other anticancer therapy within four weeks prior to PET imaging.
Exclusion Criteria:
* Patients with pregnancy or lactating;
* Patients had a second primary tumor;
* The inability or unwillingness of the research participant, parent, or legal representative to provide written informed consent.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Diagnostic performance (patient-based)
Timeframe: 2 years
Trial details
NCT IDNCT06465017
SponsorThe First Affiliated Hospital of Xiamen University