NCT06277180

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
20mo left

Started Oct 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress61%
Oct 2023Dec 2027

Study Start

First participant enrolled

October 1, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 26, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

February 26, 2024

Status Verified

February 1, 2024

Enrollment Period

2.3 years

First QC Date

February 18, 2024

Last Update Submit

February 18, 2024

Conditions

Medullary Thyroid CancerPrositron Emission TomographyFibroblast Activation Protein InhibitorSurgery

Keywords

Medullary Thyroid CancerPrositron Emission TomographyFibroblast Activation Protein InhibitorSurgery

Outcome Measures

Primary Outcomes (1)

  • 1-month post-surgery calcitonin level

    1-month post-surgery calcitonin level

    1-month post-surgery

Secondary Outcomes (3)

  • 2-year event free survival

    2-year post-surgery

  • Ratio of patient that change surgical plan

    immediately after surgery

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

    1-month post-surgery

Study Arms (3)

Newly diagnosed MTC that resect all 68Ga-TCR-FAPI-avid lesions

EXPERIMENTAL

Newly diagnosed MTC (did not receive previous surgery, radiotherapy or target therapy) and all pre-surgically identified 68Ga-TCR-FAPI-avid lesions are/can be successfully resected.

Procedure: Surgery

Recurrent/persistent MTC that resect all 68Ga-TCR-FAPI-avid lesions

EXPERIMENTAL

Recurrent/persistent MTC (underwent previous surgery with currently biochemical recurrent/residual disease) and all pre-surgically identified 68Ga-TCR-FAPI-avid lesions are/can be successfully resected.

Procedure: Surgery

Not all 68Ga-TCR-FAPI-avid lesions can be resected

EXPERIMENTAL

Not all pre-surgically identified 68Ga-TCR-FAPI-avid lesions are/can be resected.

Procedure: Surgery

Interventions

SurgeryPROCEDURE

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

Newly diagnosed MTC that resect all 68Ga-TCR-FAPI-avid lesionsRecurrent/persistent MTC that resect all 68Ga-TCR-FAPI-avid lesions

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • Be willing and able to understand the research content and provide written informed consent/assent for the trial.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, 100021, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Medullary

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Carcinoma, NeuroendocrineNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms, Ductal, Lobular, and MedullaryNeoplasms, Nerve Tissue

Central Study Contacts

Shaoyan Liu, M.D.

CONTACT

0086-010-87787190shaoyanliu.bj@263.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2024

First Posted

February 26, 2024

Study Start

October 1, 2023

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2027

Last Updated

February 26, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)