NCT05175404

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2022

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 3, 2022

Completed
21 days until next milestone

Study Start

First participant enrolled

January 24, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2023

Completed
Last Updated

March 4, 2025

Status Verified

November 1, 2024

Enrollment Period

1.5 years

First QC Date

December 14, 2021

Last Update Submit

February 27, 2025

Conditions

Thyroid Cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    60 minutes +- 5 minutes after injection 18F-PSMA-11

Secondary Outcomes (7)

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

    60 minutes +- 5 minutes after injection 18F-PSMA-11

  • Perform a lesion detection rate analysis on organ level.

    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.

    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

    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.

    60 minutes +- 5 minutes after injection 18F-PSMA-11

  • +2 more secondary outcomes

Study Arms (1)

Overal Trial

OTHER

only one arm in this trial

Diagnostic Test: PET/CT scan F18-PSMA-11

Interventions

PET/CT scan F18-PSMA-11DIAGNOSTIC_TEST

PET/CT scan with F18-PSMA-11

Overal Trial

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital Ghent

Ghent, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 39264376RESULT

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2021

First Posted

January 3, 2022

Study Start

January 24, 2022

Primary Completion

July 18, 2023

Study Completion

July 18, 2023

Last Updated

March 4, 2025

Record last verified: 2024-11

Locations

BE(1)