TumorNCT06465017
ImmunoPET Targeting Trophoblast Cell-Surface Antigen 2 (Trop-2) in Thyroid Cancer
A study testing standard-of-care imaging (18F-FDG PET/CT), 68Ga-MY6349 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 18F-FDG 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?
- standard-of-care imaging (18F-FDG PET/CT), 68Ga-MY6349 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
- 149 participants
- Where
- 1 siteChina
- Study dates
- 13 Jun 2024to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003
About this study
Official title: ImmunoPET Targeting Trophoblast Cell-Surface Antigen 2 (Trop-2) in Thyroid Cancer and Compared With 18F-FDG
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.
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 developed a Trop2-specific radiotracer for PET/CT imaging, 68Ga-MY6349, with the potential for clinical translation across various cancer types. In particular, 68Ga-MY6349 PET/CT demonstrated the highest tumor uptake in PTC across 15 cancer types, enabling visualization of more metastatic lesions than conventional 18F-FDG PET/CT.
In this study, we comprehensively evaluated the clinical utility of Trop2 PET/CT imaging for detecting recurrent and metastatic thyroid cancer, and the results were compared with standard-of-care imaging (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.
- Conditions
- Tumor, Solid Tumor, Thyroid Cancer, Positron-Emission Tomography
- Being tested
- standard-of-care imaging (18F-FDG PET/CT), 68Ga-MY6349 PET/CT
- Keywords
- Tumor, Solid, Positron-Emission Tomography, Trop-2, Diagnosis
- 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.
standard-of-care imaging (18F-FDG PET/CT), 68Ga-MY6349 PET/CTDiagnostic test
Each subject receives a single intravenous injection of standard-of-care imaging radiopharmaceuticals (18F-FDG) and 68Ga-MY6349, 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 | Experimental | Each subject receives a single intravenous injection of 68Ga-MY6349 and undergoes PET/CT imaging within the specified time. Receives: Diagnostic Test: standard-of-care imaging (18F-FDG PET/CT), 68Ga-MY6349 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 standard-of-care imaging (18F-FDG PET/CT) were calculated and compared.
Measured: 2 years
Secondary outcomes (5)
Diagnostic performance (patient-based)
Patient-based specificity of 68Ga-MY6349 PET/CT and standard-of-care imaging (18F-FDG PET/CT) were calculated and compared.
Measured: 2 years
Diagnostic performance
Lesion-based diagnostic accuracy (sensitivity, specificity, and accuracy) of 68Ga-MY6349 and standard-of-care imaging (18F-FDG PET/CT) were calculated and compared.
Measured: 2 years
SUVmax and TBR
Tumor uptake comparison between 68Ga-MY6349 PET/CT and standard-of-care imaging (18F-FDG PET/CT) at the individual lesion level were calculated and compared.
Measured: 2 years
68Ga-MY6349 safety
Patients were monitored for adverse events (AEs) during and up to 24 h after radiotracer administration. Vital signs, including body temperature, heart rate, and blood pressure, were recorded pre- and post-⁶⁸Ga-MY6349 injection.
Measured: 24 h
The impact on clinical management
Proportion of patients with change in management plan based on 68Ga-MY6349 PET/CT versus conventional imaging or 18F-FDG PET/CT, which is defiend 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 18F-FDG 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 posted18 Jun 2024
- Study start13 Jun 2024
- Primary completion31 Dec 2024
- Study completion31 Jan 2026
Why it stopped: The study was completed as planned after achieving the target enrollment and completing all protocol-specified procedures and follow-up.
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
- 149 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06465017
- Sponsor's protocol ID
- XMYY-2024KY195
- Status last verified
- Mar 2025
- First submitted
- 13 Jun 2024
- Last updated
- 28 May 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 28 May 2026. 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 Thyroid Cancer and Compared With 18F-FDG
- ClinicalTrials.gov ID
- NCT06465017
- Acronym / sponsor ID
- XMYY-2024KY195
- Conditions
- Tumor, Solid Tumor, Thyroid Cancer, Positron-Emission Tomography
- Keywords
- Tumor, Solid, Positron-Emission Tomography, Trop-2, Diagnosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was completed as planned after achieving the target enrollment and completing all protocol-specified procedures and follow-up.
- Enrolment
- 149 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- 13 Jun 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 18 Jun 2024 (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 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.
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 developed a Trop2-specific radiotracer for PET/CT imaging, 68Ga-MY6349, with the potential for clinical translation across various cancer types. In particular, 68Ga-MY6349 PET/CT demonstrated the highest tumor uptake in PTC across 15 cancer types, enabling visualization of more metastatic lesions than conventional 18F-FDG PET/CT.
In this study, we comprehensively evaluated the clinical utility of Trop2 PET/CT imaging for detecting recurrent and metastatic thyroid cancer, and the results were compared with standard-of-care imaging (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.
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 | Experimental | Diagnostic Test: standard-of-care imaging (18F-FDG PET/CT), 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
- 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 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| standard-of-care imaging (18F-FDG PET/CT), 68Ga-MY6349 PET/CTEach subject receives a single intravenous injection of standard-of-care imaging radiopharmaceuticals (18F-FDG) and 68Ga-MY6349, 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 |
Primary outcome
Diagnostic performance (patient-based)
Time frame: 2 years
The patient-based sensitivity of 68Ga-MY6349 and standard-of-care imaging (18F-FDG PET/CT) were calculated and compared.
5 secondary outcomes
Diagnostic performance (patient-based)
Time frame: 2 years
Diagnostic performance
Time frame: 2 years
SUVmax and TBR
Time frame: 2 years
68Ga-MY6349 safety
Time frame: 24 h
The impact on clinical management
Time frame: 2-4 weeks
Results and safety
The study was stopped early (reason given: The study was completed as planned after achieving the target enrollment and completing all protocol-specified procedures and follow-up.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard-of-care imaging (18F-FDG PET/CT), 68Ga-MY6349 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: stopped early, as of the sponsor's last update on 28 May 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?
The study was stopped early (reason given: The study was completed as planned after achieving the target enrollment and completing all protocol-specified procedures and follow-up.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 28 May 2026.