Medullary Thyroid CancerMIMETICNCT05534594
Evaluation of the 18F-PSMA Positron Emission Tomography (PET)/CT in Patients With Medullary Thyroid Cancer
A study testing 18F-PSMA-1007 in people with Medullary Thyroid Cancer and Medullary Thyroid Carcinoma, run by University Medical Center Groningen at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medullary Thyroid Cancer, Medullary Thyroid Carcinoma, Thyroid Carcinoma, Medullary
- What is being tested?
- 18F-PSMA-1007
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteNetherlands
- Study dates
- 19 Aug 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with prostate cancer or renal cell carcinoma
- Pregnant patients
- Recent neck surgery (<3 months ago)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Medical Centre Groningen
Groningen, Provincie Groningen, 9713 GZ
About this study
Official title: Prospective, Single-centre, Feasibility Study to Evaluate the Use of 18F-PSMA PET/CT in Patients With Biochemically Active Medullary Thyroid Cancer
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.
Read more
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
- Medullary Thyroid Cancer, Medullary Thyroid Carcinoma, Thyroid Carcinoma, Medullary, Thyroid Cancer, Medullary
- Being tested
- 18F-PSMA-1007
- 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
- Medical subject headings
- Carcinoma, Medullary, Thyroid cancer, medullary, Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-PSMA-1007Drug
Also called Fluorine-18 labeled prostate specific membrane antigen
As explained under 'Arms'.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Medullary Thyroid Cancer undergoing 18F-PSMA PET/CT | Experimental | 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. Receives: Drug: 18F-PSMA-1007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of 18F-PSMA PET/CT for medullary thyroid cancer.
Patient- and lesion-based sensitivity.
Measured: Up to 2 years
Secondary outcomes (5)
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).
Measured: Up to 2 years
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.
Measured: Up to 2 years
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.
Measured: Up to 2 years
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.
Measured: Up to 2 years
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.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start19 Aug 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medullary Thyroid CancerStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05534594
- Sponsor's protocol ID
- 202200014
- Acronym
- MIMETIC
- Status last verified
- Jun 2025
- First submitted
- 25 Aug 2022
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single-centre, Feasibility Study to Evaluate the Use of 18F-PSMA PET/CT in Patients With Biochemically Active Medullary Thyroid Cancer
- ClinicalTrials.gov ID
- NCT05534594
- Acronym / sponsor ID
- MIMETIC / 202200014
- Conditions
- Medullary Thyroid Cancer, Medullary Thyroid Carcinoma, Thyroid Carcinoma, Medullary, Thyroid Cancer, Medullary
- 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
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 19 Aug 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 9 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Medullary Thyroid Cancer undergoing 18F-PSMA PET/CT | Experimental | Drug: 18F-PSMA-1007Only 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Patients with prostate cancer or renal cell carcinoma
- Pregnant patients
- Recent neck surgery (<3 months ago)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-PSMA-1007Also: Fluorine-18 labeled prostate specific membrane antigenAs explained under 'Arms'. | Drug | Patients with Medullary Thyroid Cancer undergoing 18F-PSMA PET/CT |
Primary outcome
Sensitivity of 18F-PSMA PET/CT for medullary thyroid cancer.
Time frame: Up to 2 years
Patient- and lesion-based sensitivity.
5 secondary outcomes
Comparison of the performance of the 18F-PSMA PET/CT to a clinically performed 18F-FDG PET/CT.
Time frame: Up to 2 years
Correlation between 18F-PSMA uptake in tumor lesions and serum calcitonin values.
Time frame: Up to 2 years
Correlation between 18F-PSMA uptake in tumor lesions and serum carcinoembryonic antigen (CEA) values.
Time frame: Up to 2 years
Correlation between 18F-FDG uptake in tumor lesions and serum calcitonin values.
Time frame: Up to 2 years
Correlation between 18F-FDG uptake in tumor lesions and serum carcinoembryonic antigen (CEA) values.
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-PSMA-1007 in people with Medullary Thyroid Cancer and Medullary Thyroid Carcinoma, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of 18F-PSMA PET/CT for medullary thyroid cancer. (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.