Thyroid CancerPhase 2NCT05175404
Use of 18F-PSMA-11 PET for Detection of Lesions in Iodine Refractory Thyroid Cancers
A Phase 2 study testing PET/CT scan F18-PSMA-11 in people with Thyroid Cancer, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Determine the diagnostic value of 18F-PSMA-11 in patients with iodine refractory thyroid cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- PET/CT scan F18-PSMA-11
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteBelgium
- Study dates
- 24 Jan 2022to 18 Jul 2023
- Phase
- Phase 2
- 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
- Patient is 18 years or older.
- Signed Informed Consent.
- Subject is diagnosed with a histologically confirmed differentiated thyroid carcinoma, that is considered RAI refractory. There is evidence of persisting or recurrent disease, based on serum thyroglobulin levels and/or medical imaging.
- Subject should have a routine clinical 18F-FDG PET/CT performed within two months prior to the study scan.
- Female patients should be either post-menopausal, surgically sterile, or using highly effective contraceptives (methods that can achieve a failure rate of less than 1%: combined hormonal contraception, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner, sexual abstinence).
Who cannot join
- Patient has a known other active malignancy.
- Subject is potentially pregnant (urinary test can be performed in case of doubt) or breastfeeding.
- Patient is mentally or legally incapacitated.
Trial locations and contacts
1 site in 1 country.
About this study
Determine the diagnostic value of 18F-PSMA-11 in patients with iodine refractory thyroid cancer.
- Conditions
- Thyroid Cancer
- Being tested
- PET/CT scan F18-PSMA-11
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CT scan F18-PSMA-11Diagnostic test
PET/CT scan with F18-PSMA-11
| Study group | Role | What they receive |
|---|---|---|
| Overal Trial | Other | only one arm in this trial Receives: Diagnostic Test: PET/CT scan F18-PSMA-11 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate uptake of 18F-PSMA-11 in RAI-RTC
Confirmation in PET-scan that lesions in RAI-RTC show uptake of 18F-PSMA-11, above background activity in the bloodpool.
Measured: 60 minutes +- 5 minutes after injection 18F-PSMA-11
Secondary outcomes (7)
Perform a semi-quantitative analysis of radiotracer uptake in lesions.
Measured: 60 minutes +- 5 minutes after injection 18F-PSMA-11
Perform a lesion detection rate analysis on organ level.
Measured: 60 minutes +- 5 minutes after injection 18F-PSMA-11
Compare uptake of 18F-PSMA-11 in these patients to the uptake of 18F-FDG, on a lesion basis.
Measured: 60 minutes +- 5 minutes after injection 18F-PSMA-11
Evaluate the sufficiency of uptake of 18F-PSMA-11 to consider therapy with 177Lu-PSMA in a subset of patients
Measured: 60 minutes +- 5 minutes after injection 18F-PSMA-11
Compare the histological expression of PSMA on already available tumor samples with the uptake of lesions on PSMA PET.
Measured: 60 minutes +- 5 minutes after injection 18F-PSMA-11
Analyse the correlation between the serum level of PSMA and the uptake on PSMA PET
Measured: 60 minutes +- 5 minutes after injection 18F-PSMA-11
Compare the histological expression of PSMA on already available tumor samples with the serum level of PSMA.
Measured: Within 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2022
- Study start24 Jan 2022
- Primary completion18 Jul 2023
- Study completion18 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05175404
- Sponsor's protocol ID
- BC-09501
- Status last verified
- Nov 2024
- First submitted
- 14 Dec 2021
- Last updated
- 4 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Van den Broeck B, Debacker JM, Bauters W, Creytens D, Ferdinande L, Huvenne W, Lapauw B, Schelfhout V, Van Laeken N, Verroken C. Potential application of [18F]AlF-PSMA-11 PET/CT in radioiodine refractory thyroid carcinoma. EJNMMI Res. 2024 Sep 12;14(1):82. doi: 10.1186/s13550-024-01148-9.
PubMed 39264376
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of 18F-PSMA-11 PET for Detection of Lesions in Iodine Refractory Thyroid Cancers
- ClinicalTrials.gov ID
- NCT05175404
- Acronym / sponsor ID
- BC-09501
- Conditions
- Thyroid Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- 18 Jul 2023 (actual)
- Study completion
- 18 Jul 2023 (actual)
- First posted
- 3 Jan 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.
Determine the diagnostic value of 18F-PSMA-11 in patients with iodine refractory thyroid cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Overal Trial | Other | Diagnostic Test: PET/CT scan F18-PSMA-11only one arm in this trial |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient is 18 years or older.
- Signed Informed Consent.
- Subject is diagnosed with a histologically confirmed differentiated thyroid carcinoma, that is considered RAI refractory. There is evidence of persisting or recurrent disease, based on serum thyroglobulin levels and/or medical imaging.
- Subject should have a routine clinical 18F-FDG PET/CT performed within two months prior to the study scan.
- Female patients should be either post-menopausal, surgically sterile, or using highly effective contraceptives (methods that can achieve a failure rate of less than 1%: combined hormonal contraception, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner, sexual abstinence).
Key exclusion criteria (3 listed)
- Patient has a known other active malignancy.
- Subject is potentially pregnant (urinary test can be performed in case of doubt) or breastfeeding.
- Patient is mentally or legally incapacitated.
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 |
|---|---|---|
| PET/CT scan F18-PSMA-11PET/CT scan with F18-PSMA-11 | Diagnostic test | Overal Trial |
Primary outcome
Demonstrate uptake of 18F-PSMA-11 in RAI-RTC
Time frame: 60 minutes +- 5 minutes after injection 18F-PSMA-11
Confirmation in PET-scan that lesions in RAI-RTC show uptake of 18F-PSMA-11, above background activity in the bloodpool.
7 secondary outcomes
Perform a semi-quantitative analysis of radiotracer uptake in lesions.
Time frame: 60 minutes +- 5 minutes after injection 18F-PSMA-11
Perform a lesion detection rate analysis on organ level.
Time frame: 60 minutes +- 5 minutes after injection 18F-PSMA-11
Compare uptake of 18F-PSMA-11 in these patients to the uptake of 18F-FDG, on a lesion basis.
Time frame: 60 minutes +- 5 minutes after injection 18F-PSMA-11
Evaluate the sufficiency of uptake of 18F-PSMA-11 to consider therapy with 177Lu-PSMA in a subset of patients
Time frame: 60 minutes +- 5 minutes after injection 18F-PSMA-11
Compare the histological expression of PSMA on already available tumor samples with the uptake of lesions on PSMA PET.
Time frame: 60 minutes +- 5 minutes after injection 18F-PSMA-11
Analyse the correlation between the serum level of PSMA and the uptake on PSMA PET
Time frame: 60 minutes +- 5 minutes after injection 18F-PSMA-11
Compare the histological expression of PSMA on already available tumor samples with the serum level of PSMA.
Time frame: Within 1 year
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 4 Mar 2025.
- Results publication: PubMed 39264376Van den Broeck B, Debacker JM, Bauters W, Creytens D, Ferdinande L, Huvenne W, Lapauw B, Schelfhout V, Van Laeken N, Verroken C. Potential application of [18F]AlF-PSMA-11 PET/CT in radioiodine refractory thyroid carcinoma. EJNMMI Res. 2024 Sep 12;14(1):82. doi: 10.1186/s13550-024-01148-9.
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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 Phase 2 study testing PET/CT scan F18-PSMA-11 in people with Thyroid Cancer, run by University Hospital, Ghent at 1 site in Belgium.
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 5 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 4 Mar 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 Belgium. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Demonstrate uptake of 18F-PSMA-11 in RAI-RTC (time frame: 60 minutes +- 5 minutes after injection 18F-PSMA-11). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05175404, which also lists 1 linked publication.
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 4 Mar 2025.