[18F]AlF-PSMA-11 PET in advanced thyroid and head and neck carcinoma

Phase 1

Recruiting

• Conditions: Head and neck squamous cell carcinoma, thyroid carcinoma; Therapeutic area: Diseases [C] - Neoplasms [C04]; Therapeutic area: Diseases [C] - Otorhinolaryngologic Diseases [C09]; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

• Registration Number: CTIS2022-503036-13-00
• Lead Sponsor: niversitair Ziekenhuis Gent

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-25
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

18 years of age or older, willing and mentally and legally capable of providing written informed consent, have = 1 measurable lesion of interest of = 1.0 cm on medical imaging

Exclusion Criteria

simultaneous active malignancy that is not TC or mucosal HNSCC, potentially pregnant female patients refusing pregnancy testing at screening, pregnant or breastfeeding female patients

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: demonstrate uptake of [¹8F]AlF-PSMA-11 in lesions on PET.;Secondary Objective: compare lesion uptake of [¹8F]AlF-PSMA-11 to that of [¹8F]FDG on PET, compare lesion uptake of [¹8F]AlF-PSMA-11 to that of radioiodine on thyroid scintigraphy, assess biodistribution and organ-specific dosimetry analysis of [¹8F]AlF-PSMA-11 using PET;Primary end point(s): qualitative count of lesions with significant [¹8F]AlF-PSMA-11 uptake on PET. For each subject, all endpoints are measured within 12 months after the last trial-specific intervention (trial-specific PET/CT or blood sampling) for that subject (LTIS). For the whole trial, all endpoints are measured within 12 months after the overall last trial-specific intervention (LTI), that is, after the last of all LTISs.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):semiquantitative lesion radiotracer [¹8F]AlF-PSMA-11 uptake values on PET. For each subject, all endpoints are measured within 12 months after LTIS. For the whole trial, all endpoints are measured within 12 months after LTI.;Secondary end point(s):semiquantitative organ-level radiotracer [¹8F]AlF-PSMA-11 uptake values on PET. For each subject, all endpoints are measured within 12 months after LTIS. For the whole trial, all endpoints are measured within 12 months after LTI.