TumorNCT07753499
Trophoblast Cell-Surface Antigen 2 (Trop-2) Targeted PET/CT in Recurrent and Metastatic Thyroid Cancer
A study testing Compared the diagnostic performance of 68Ga-MY6349 PET/CT with 68Ga-FAPI PET/CT in people with Tumor and Solid Tumor, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
Trial 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 68Ga-FAPI PET/CT. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Tumor, Solid Tumor, Thyroid Cancer
- What is being tested?
- Compared the diagnostic performance of 68Ga-MY6349 PET/CT with 68Ga-FAPI PET/CT
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to 31 Dec 2027
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 68Ga-MY6349 and 68Ga-FAPI PET/CT 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.
Who cannot join
- Pregnant or lactating patients;
- Patients with a second primary tumor;
- The inability or unwillingness of the research participant, parent, or legal representative to provide written informed consent.
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
The First Affiliated Hospital of Xiamen University, Xiamen, Fujian 361000
Xiamen, Fujian, 361000
Haojun Chen, MD, PhD, 86-592-2137077, leochen0821@foxmail.com
Hao Fu, MD, PhD, 15959230059, fuhaonuclear@163.com
About this study
Official title: Trophoblast Cell-Surface Antigen 2 (Trop-2) Targeted PET/CT in Recurrent and Metastatic Thyroid Cancer and Compared With 68Ga-FAPI PET/CT
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 68Ga-FAPI 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 68Ga-FAPI PET/CT, and the impact on clinical management.
Read the detailed description
Trophoblast cell-surface antigen 2 (Trop2), a transmembrane glycoprotein, is highly expressed in most epithelial cancers but has low expression in most normal tissues. Notably, Trop2 expression is significantly elevated in thyroid cancer, representing an important molecular hallmark of thyroid cancer. Previously, we evaluated the diagnostic performance of 68Ga-MY6349 PET/CT in recurrent and metastatic thyroid cancer and compared it with 18F-FDG PET/CT. The results demonstrated that 68Ga-MY6349 PET/CT was superior to 18F-FDG PET/CT for lesion detection, particularly in patients with PTC and TENIS. In addition, fibroblast activation protein is highly expressed in cancer-associated fibroblasts in thyroid cancer. 68Ga-labeled FAP inhibitor (FAPI) has demonstrated favorable in vivo pharmacokinetics and higher diagnostic accuracy than 18F-FDG in various types of cancers, including thyroid cancer.
In this study, we comprehensively evaluated the clinical utility of 68Ga-MY6349 PET/CT imaging for detecting recurrent and metastatic thyroid cancer, and the results were compared with 68Ga-FAPI 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 68Ga-FAPI PET/CT, and the impact on clinical management.
- Conditions
- Tumor, Solid Tumor, Thyroid Cancer
- Being tested
- Compared the diagnostic performance of 68Ga-MY6349 PET/CT with 68Ga-FAPI PET/CT
- Keywords
- Tumor, Thyroid cancer, TENIS, Trop-2, FAP, Diagnosis, PET/CT
- Medical subject headings
- Neoplasms, Thyroid Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compared the diagnostic performance of 68Ga-MY6349 PET/CT with 68Ga-FAPI PET/CTDiagnostic test
Each subject receives a single intravenous injection of 68Ga-MY6349 and 68Ga-FAPI and undergoes PET/CT imaging within the specified time. For participants who were not radioiodine-refractory or who did not have MTC or ATC, DxWBS was conducted. Each participant received an intramuscular injection of rhTSH on two consecutive days, followed by the oral administration of 131I. DxWBS was performed 2 days after 131I administration
| 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: Compared the diagnostic performance of 68Ga-MY6349 PET/CT with 68Ga-FAPI PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance (patient-based)
The patient-based sensitivity of 68Ga-MY6349 and 68Ga-FAPI PET/CT) were calculated and compared.
Measured: 2 years
Secondary outcomes (4)
Diagnostic performance (patient-based)
Patient-based specificity of 68Ga-MY6349 PET/CT and 68Ga-FAPI PET/CT) were calculated and compared.
Measured: 2 years
Diagnostic performance
Lesion-based diagnostic accuracy (sensitivity, specificity, and accuracy) of 68Ga-MY6349 and 68Ga-FAPI PET/CT were calculated and compared.
Measured: 2 years
SUVmax and TBR
Tumor uptake comparison between 68Ga-MY6349 PET/CT and 68Ga-FAPI PET/CT at the individual lesion level were calculated and compared.
Measured: 2 years
The impact on clinical management
Proportion of patients with change in management plan based on 68Ga-MY6349 PET/CT versus conventional imaging or 68Ga-FAPI PET/CT, which is defined as the proportion of patients whose clinical management strategy was modified based on 68Ga-MY6349 PET/CT findings, compared to the initial plan derived from conventional imaging or 68Ga-FAPI PET/CT.
Measured: 2-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Xiamen UniversityThe sponsor's other registered studies.
- 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
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07753499
- Sponsor's protocol ID
- XMYY-2026KY052
- Status last verified
- Jul 2026
- First submitted
- 4 Aug 2026
- Last updated
- 7 Aug 2026
- 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 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trophoblast Cell-Surface Antigen 2 (Trop-2) Targeted PET/CT in Recurrent and Metastatic Thyroid Cancer and Compared With 68Ga-FAPI PET/CT
- ClinicalTrials.gov ID
- NCT07753499
- Acronym / sponsor ID
- XMYY-2026KY052
- Conditions
- Tumor, Solid Tumor, Thyroid Cancer
- Keywords
- Tumor, Thyroid cancer, TENIS, Trop-2, FAP, Diagnosis, PET/CT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 7 Aug 2026 (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.
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 68Ga-FAPI 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 68Ga-FAPI PET/CT, and the impact on clinical management.
Detailed description
Trophoblast cell-surface antigen 2 (Trop2), a transmembrane glycoprotein, is highly expressed in most epithelial cancers but has low expression in most normal tissues. Notably, Trop2 expression is significantly elevated in thyroid cancer, representing an important molecular hallmark of thyroid cancer. Previously, we evaluated the diagnostic performance of 68Ga-MY6349 PET/CT in recurrent and metastatic thyroid cancer and compared it with 18F-FDG PET/CT. The results demonstrated that 68Ga-MY6349 PET/CT was superior to 18F-FDG PET/CT for lesion detection, particularly in patients with PTC and TENIS. In addition, fibroblast activation protein is highly expressed in cancer-associated fibroblasts in thyroid cancer. 68Ga-labeled FAP inhibitor (FAPI) has demonstrated favorable in vivo pharmacokinetics and higher diagnostic accuracy than 18F-FDG in various types of cancers, including thyroid cancer.
In this study, we comprehensively evaluated the clinical utility of 68Ga-MY6349 PET/CT imaging for detecting recurrent and metastatic thyroid cancer, and the results were compared with 68Ga-FAPI 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 68Ga-FAPI PET/CT, and the impact on clinical management.
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: Compared the diagnostic performance of 68Ga-MY6349 PET/CT with 68Ga-FAPI PET/CTEach subject receives a single intravenous injection of 68Ga-MY6349 and undergoes PET/CT imaging within the specified time. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 68Ga-MY6349 and 68Ga-FAPI PET/CT 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.
Key exclusion criteria (3 listed)
- Pregnant or lactating patients;
- Patients with a second primary tumor;
- The inability or unwillingness of the research participant, parent, or legal representative to provide written informed consent.
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 |
|---|---|---|
| Compared the diagnostic performance of 68Ga-MY6349 PET/CT with 68Ga-FAPI PET/CTEach subject receives a single intravenous injection of 68Ga-MY6349 and 68Ga-FAPI and undergoes PET/CT imaging within the specified time. For participants who were not radioiodine-refractory or who did not have MTC or ATC, DxWBS was conducted. Each participant received an intramuscular injection of rhTSH on two consecutive days, followed by the oral administration of 131I. DxWBS was performed 2 days after 131I administration | Diagnostic test | 68Ga-MY6349 PET/CT |
Primary outcome
Diagnostic performance (patient-based)
Time frame: 2 years
The patient-based sensitivity of 68Ga-MY6349 and 68Ga-FAPI PET/CT) were calculated and compared.
4 secondary outcomes
Diagnostic performance (patient-based)
Time frame: 2 years
Diagnostic performance
Time frame: 2 years
SUVmax and TBR
Time frame: 2 years
The impact on clinical management
Time frame: 2-4 weeks
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 7 Aug 2026.
Related trials for Tumor
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compared the diagnostic performance of 68Ga-MY6349 PET/CT with 68Ga-FAPI PET/CT in people with Tumor and Solid Tumor, run by The First Affiliated Hospital of Xiamen University 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 5 inclusion and 3 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 7 Aug 2026. 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 Haojun Chen, MD, PhD (18659285282, leochen0821@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance (patient-based) (time frame: 2 years). 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 7 Aug 2026.