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Completed

NCT Number: NCT05175404

Use of 18F-PSMA-11 PET for Detection of Lesions in Iodine Refractory Thyroid Cancers

Determine the diagnostic value of 18F-PSMA-11 in patients with iodine refractory thyroid cancer.

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Key information

Conditions

Thyroid Cancer Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Thyroid Diseases Thyroid Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University hospital Ghent

Ghent, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

PET/CT scan F18-PSMA-11

Diagnostic Test

PET/CT scan with F18-PSMA-11

Primary outcomes

  1. 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.

Secondary outcomes

  1. Perform a semi-quantitative analysis of radiotracer uptake in lesions.

    Time frame: 60 minutes +- 5 minutes after injection 18F-PSMA-11

  2. Perform a lesion detection rate analysis on organ level.

    Time frame: 60 minutes +- 5 minutes after injection 18F-PSMA-11

  3. 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

  4. 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

  5. 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

  6. 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

  7. Compare the histological expression of PSMA on already available tumor samples with the serum level of PSMA.

    Time frame: Within 1 year

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 3, 2022
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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