Health TrialsbyHealthPanel

68Ga-TCR-FAPI PET/CT Guided Precision Surgery for MTC

ConditionsMedullary Thyroid CancerPrositron Emission TomographyFibroblast Activation Protein InhibitorSurgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

This is a phase II clinical trial to evaluate the capability of 68Ga-labeled targeted covalent radiopharmaceutical (TCR) fibroblast activation protein inhibitor (FAPI) PET/CT to guide the surgical treatment of medullary thyroid carcinoma (MTC). The surgical extent of MTC is determined based on the lesion range revealed by 68Ga-TCR-FAPI PET/CT, with the main endpoint being 1-month post-surgical calcitonin level.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 18 and 75 years；

Diagnosed with MTC and have surgical indication based on preliminary evaluation; the tumor may be newly diagnosed or previously treated;

Expected survival of at least 12 weeks;

No major organ dysfunction (heart, lung, liver, kidney and other major organ include), acute or life-threatening status of infection;

Disqualifiers

Have a history of imaging agent allergies;

Does not meet the PET-CT scan sedation requirements, or has contraindications for PET-CT examination;

Be pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial;

No surgical indication (i.e., no measurable disease, unresectable disease, or significant present of distant metastasis), refusing surgery or 68Ga-TCR-FAPI PET/CT-guided surgery.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Surgery

    Procedure/Surgery

    Surgery is performed based on the lesion range revealed by 68Ga-TCR-FAPI PET/CT, and all 68Ga-TCR-FAPI-avid lesions are resected.

  • Surgery

    Procedure/Surgery

    68Ga-TCR-FAPI PET/CT identified distant metastasis or unresectable lesions, but the patient is still recommended to undergo surgery for debulking or reduce symptoms.

Treatment groups

50 Participants
are divided into 3 treatment groups
Group A: Newly diagnosed MTC that resect all 68Ga-TCR-FAPI-avid lesionsExperimental treatment 1 intervention
Group B: Recurrent/persistent MTC that resect all 68Ga-TCR-FAPI-avid lesionsExperimental treatment 1 intervention
Group C: Not all 68Ga-TCR-FAPI-avid lesions can be resectedExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

1-month post-surgery calcitonin level

1-month post-surgery calcitonin level

Time frame
1-month post-surgery

Secondary outcomes

1

2-year event free survival

2-year event free survival

Time frame
2-year post-surgery
2

Ratio of patient that change surgical plan

Ratio of patient that change surgical plan

Time frame
immediately after surgery
3

Accuracy, sensitivity, specificity of 68Ga-TCR-FAPI PET/CT in identifying MTC lesions

Accuracy, sensitivity, specificity of 68Ga-TCR-FAPI PET/CT in identifying MTC lesions

Time frame
1-month post-surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Lead sponsor

Peking University

Collaborator

Peking University Cancer Hospital & Institute

Collaborator

Source ClinicalTrials.gov
Apply now