Clinical trial · Interventional
Evaluation of the 18F-PSMA Positron Emission Tomography (PET)/CT in Patients With Medullary Thyroid Cancer
Prospective, Single-centre, Feasibility Study to Evaluate the Use of 18F-PSMA PET/CT in Patients With Biochemically Active Medullary Thyroid Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Medullary Thyroid Cancer | Thyroid Gland Medullary Carcinoma | ALIAS | 0.90 |
| Medullary Thyroid Carcinoma | Thyroid Gland Medullary Carcinoma | ALIAS | 0.90 |
| Thyroid Cancer, Medullary | Thyroid Gland Medullary Carcinoma | ALIAS | 0.90 |
| Thyroid Carcinoma, Medullary | Thyroid Gland Medullary Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-PSMA-1007 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with Medullary Thyroid Cancer undergoing 18F-PSMA PET/CT
- description
- Only 1 arm exists in this study. Patients with Medullary Thyroid Cancer undergo a PET/CT after receiving the Fluorine-18 labeled prostate specific membrane antigen (18F-PSMA-1007) tracer intravenously. Each patient will undergo this process one time. Patients will receive 3 MBq/kg (+- 10%) in 8,3 ml (maximum 400 MBq). Waiting time after injection is 60 minutes. Scanning time is approximately 45 minutes.
- interventionNames
- Drug: 18F-PSMA-1007
Primary outcomes (1)
- measure
- Sensitivity of 18F-PSMA PET/CT for medullary thyroid cancer.
- timeFrame
- Up to 2 years
- description
- Patient- and lesion-based sensitivity.
Secondary outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available