Patients with a iodine refractory thyroid carcinoma, who received an 18F -FDG PET/CT scan in routine clinical practice.
Conditions
Interventions
Product Name: [18F] PSMA-11
Pharmaceutical Form: Solution for injection
INN or Proposed INN: [18F]PSMA-11
Other descriptive name: [18F]AlF-HBED-CC-PSMA
Concentration unit: GBq/ml gigabecquerel/millil
Sponsors
University Hospital Ghent
Eligibility
Sex/Gender
All
Inclusion criteria
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. - 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 effective contraceptive methods (failure rate less than 1% per year when used consistently and correctly: combined hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner, sexual abstinence). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: - Patient has known other active malignancy. - Patient is potentially pregnant (urinary hCG test can be performed in case of doubt) or breastfeeding. - Patient is mentally or legally incapacitated.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Demonstrate uptake of 18F-PSMA-11 in lesions in a radio-active iodine refractive thyroid carcinoma (RAI-RTC), either local recurrent disease, lymph nodes or distant metastasis. ;Secondary Objective: -Perform a semi-quantitative analysis of radiotracer uptake in lesions. -Perform a lesion detection rate analysis on organ level. -Compare uptake of 18F-PSMA-11 in these patients to the uptake of 18F-FDG, on a lesion basis as well as on a patient basis. -Evaluate the sufficiency of uptake of 18F-PSMA-11 to consider therapy with 177Lu-PSMA in a subset of patients. -Compare the histological expression of PSMA on the primary tumor with the uptake of lesions on PSMA PET. -Analyse the correlation between the serum level of PSMA and the uptake on PSMA PET. -Compare the histological expression of PSMA on the primary tumor with the serum level of PSMA. ;Primary end point(s): Confirmation in PET-scan that lesions in RAI-RTC show uptake of 18F-PSMA-11, above background activity in the bloodpool.;Timepoint(s) of evaluation of this end point: After 60 minutes (+- 5 minutes) post injection | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Perform a semi-quantitative analysis of radiotracer uptake in lesions. o Standard uptake value (SUV) measurements will be performed: SUVmax for lesions and SUVmean for background areas. o Total metabolic tumor volume (MTV) measurements based on 41% of SUVpeak. - Perform a lesion detection rate analysis on organ level. o Lesion count per organ - Compare uptake of 18F-PSMA-11 in these patients to the uptake of 18F-FDG, on a lesion basis. o Comparison of SUV values of each lesion in both tracers. o Evaluation if any lesions are only visible with either FDG or PSMA. - Evaluate the sufficiency of uptake of 18F-PSMA-11 to consider therapy with 177Lu-PSMA in a subset of patients. o Lesions have an SUVmax value of at least 1.5 times the uptake in the liver and there is no major tumor load visible on FDG PET that is not PSMA avid. Criteria used by Hofmann et al. in a phase 2 study for prostate cancer (Hofman MS) - Compare the histological expression of PSMA on already available tumor samples with the uptake of lesions on PSMA PET. o Expression of PSMA defined as negative, score 0 (0-5% expression), moderately positive, score 1 (6-50%) or highly positive, score 2 (51-100%) o Comparison of this score with MTV values of PSMA PET. - Analyse the correlation between the serum level of PSMA and the uptake on PSMA PET. o Comparison of the value in the serum PSMA with MTV values of PSMA PET, grouped in male and female patient population (Beckett ML) - Compare the histological expression of PSMA on the primary tumor with the serum level of PSMA. o Expression of PSMA defined as negative, score 0 (0-5% expression), moderately positive, score 1 (6-50%) or highly positive, score 2 (51-100%) o Comparison of this score with PSMA values in the serum.;Timepoint(s) of evaluation of this end point: After 60 minutes (+- 5 minutes) post injection. Analyses will be done within max. 1 year after LSLV. | — |
Countries
Belgium
Contacts
Public ContactHIRUZ CTU
University Hospital Ghent
Outcome results
None listed