Evaluation of the 18F-PSMA Positron Emission Tomography (PET)/CT in Patients With Medullary Thyroid Cancer

Medullary Thyroid Cancer Clinical Trial

— MIMETIC  

Official title:

Prospective, Single-centre, Feasibility Study to Evaluate the Use of 18F-PSMA PET/CT in Patients With Biochemically Active Medullary Thyroid Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05534594
• Other study ID #: 202200014
• Status: Recruiting
• Phase: N/A
• Start date: August 19, 2022
• Est. completion date: December 2024

Study information

• Verified date: October 2022
• Source: University Medical Center Groningen
• Contact: Adrienne H. Brouwers, MD, PhD
• Phone: +31503612832
• Email: a.h.brouwers[@]umcg.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Rationale: In patients with medullary thyroid cancer (MTC), molecular imaging is used to assess the extent of disease in the primary diagnostic process and follow-up period to determine possible therapeutic options. The currently most used tracer in clinical practice, F-18 labelled fluorodeoxyglucose (18F-FDG), does not accurately detect MTC tumors with an indolent growth rate. A new, complimentary tracer is warranted to detect different subtypes.

Objective: The primary objective is to assess the feasibility of using the F-18 labelled prostate specific membrane antigen (18F-PSMA) PET/CT for (re)staging patients with medullary thyroid cancer. The secondary objective is to compare the ability to detect MTC with the 18F-PSMA PET/CT to that of the 18F-FDG PET/CT.

Study design: Prospective, single-centre, feasibility study.

Study population: Patients (18 years of age or older) with biochemically and cytological/histological confirmed MTC, for whom the indication of an 18F-FDG PET/CT for tumor staging has already been determined on clinical grounds.

Main study parameters/endpoints: The primary outcome of this study is the performance (lesion-based//patient-based sensitivity) of the 18F-PSMA PET to detect MTC lesions in patients with cytologically/histologically confirmed disease. Secondarily, the performance of the 18F-PSMA PET will be compared to the 18F-FDG PET/CT.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• Histological or cytological proven MTC

• Biochemical evidence of disease activity (elevated/increasing calcitonin and/or CEA)

• Clinical indication for an 18F-FDG PET/CT

• Able to follow instructions to participate in the study

• Able to give informed consent

Exclusion Criteria:

• Patients with prostate cancer or renal cell carcinoma

• Pregnant patients

• Recent neck surgery (<3 months ago)

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Neuroendocrine
• Medullary Thyroid Cancer
• Medullary Thyroid Carcinoma
• Thyroid Cancer, Medullary
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Drug:
• 18F-PSMA-1007
As explained under 'Arms'.

Locations

Country	Name	City	State
Netherlands	University Medical Centre Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of 18F-PSMA PET/CT for medullary thyroid cancer.	Patient- and lesion-based sensitivity.	Up to 2 years
Secondary	Comparison of the performance of the 18F-PSMA PET/CT to a clinically performed 18F-FDG PET/CT.	Comparison of patient- and lesion-based sensitivity. Comparison of Standardized Uptake Values (SUVs).	Up to 2 years
Secondary	Correlation between 18F-PSMA uptake in tumor lesions and serum calcitonin values.	Assess the correlation between 18F-PSMA uptake and serum calcitonin (ng/L) values.	Up to 2 years
Secondary	Correlation between 18F-PSMA uptake in tumor lesions and serum carcinoembryonic antigen (CEA) values.	Assess the correlation between 18F-PSMA uptake and serum CEA (ug/L) values.	Up to 2 years
Secondary	Correlation between 18F-FDG uptake in tumor lesions and serum calcitonin values.	Assess the correlation between 18F-FDG uptake and serum calcitonin (ng/L) values.	Up to 2 years
Secondary	Correlation between 18F-FDG uptake in tumor lesions and serum carcinoembryonic antigen (CEA) values.	Assess the correlation between 18F-FDG uptake and serum CEA (ug/L) values.	Up to 2 years