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Trial Title:
Evaluation of the 18F-PSMA Positron Emission Tomography (PET)/CT in Patients With Medullary Thyroid Cancer
NCT ID:
NCT05534594
Condition:
Medullary Thyroid Cancer
Medullary Thyroid Carcinoma
Thyroid Carcinoma, Medullary
Thyroid Cancer, Medullary
Conditions: Official terms:
Carcinoma
Thyroid Neoplasms
Carcinoma, Neuroendocrine
Carcinoma, Medullary
Thyroid Diseases
Conditions: Keywords:
PSMA PET/CT
18F-PSMA PET/CT
Fluorine-18 Labeled Prostate Specific Membrane Antigen
Prostate Specific Membrane Antigen
Thyroid Cancer
Medullary Thyroid Cancer
Medullary Thyroid Carcinoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
18F-PSMA-1007
Description:
As explained under 'Arms'.
Arm group label:
Patients with Medullary Thyroid Cancer undergoing 18F-PSMA PET/CT
Other name:
Fluorine-18 labeled prostate specific membrane antigen
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.
Criteria for eligibility:
Criteria:
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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University Medical Centre Groningen
Address:
City:
Groningen
Zip:
9713 GZ
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Adrienne H. Brouwers, MD, PhD
Phone:
+31503612832
Email:
a.h.brouwers@umcg.nl
Start date:
August 19, 2022
Completion date:
December 2024
Lead sponsor:
Agency:
University Medical Center Groningen
Agency class:
Other
Source:
University Medical Center Groningen
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05534594
