ImmunoPET Targeting Trophoblast Cell-Surface Antigen 2 (Trop-2) in Thyroid Cancer

NCT06465017 | Terminated

• 1 other identifier: XMYY-2024KY195
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Solid Tumor; Thyroid Cancer; Positron-Emission Tomography; Tumor

Keywords

Tumor; Solid; Positron-Emission Tomography; Trop-2; Diagnosis

Outcome Measures

Primary Outcomes (1)

• Diagnostic performance (patient-based)

  The patient-based sensitivity of 68Ga-MY6349 and standard-of-care imaging (18F-FDG PET/CT) were calculated and compared.

  2 years

Secondary Outcomes (5)

• Diagnostic performance (patient-based)

  2 years

• Diagnostic performance

  2 years

• SUVmax and TBR

  2 years

• 68Ga-MY6349 safety

  24 h

• The impact on clinical management

  2-4 weeks

Study Arms (1)

68Ga-MY6349

EXPERIMENTAL

Each subject receives a single intravenous injection of 68Ga-MY6349 and undergoes PET/CT imaging within the specified time.

Diagnostic Test: standard-of-care imaging (18F-FDG PET/CT), 68Ga-MY6349 PET/CT

Interventions

standard-of-care imaging (18F-FDG PET/CT), 68Ga-MY6349 PET/CT DIAGNOSTIC_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

68Ga-MY6349

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead

Study Sites (1)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361003, China

Location

MeSH Terms

Conditions

Neoplasms; Thyroid Neoplasms; Disease

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 18, 2024
• Study Start: January 15, 2024
• Primary Completion: December 31, 2024
• Study Completion: January 31, 2026
• Last Updated: April 20, 2026

Record last verified: 2025-03

Locations

CN (1)