A Study to Evaluate GEH200520/GEH200521 (18F) Safety and Tolerability When Used for PET Scans in Patients With Solid Tumour Malignancies

PHASE1RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

January 27, 2023

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Malignant Solid TumorOncology
Interventions
DRUG

GEH200520 Injection / GEH200521 (18F) Injection - Part A

Administration of GEH200520 Injection followed within 2 to 4 minutes by GEH200521 (18F) Injection followed by a 10mL saline flush

DIAGNOSTIC_TEST

Dynamic and Static - PET/CT scan

Dynamic whole-body PET/CT scan starting at the time of injection (sequential scans over 90 minutes anticipated) followed by static whole-body scans starting at 150 minutes, 270 minutes, and (optional) 24 hours after injection.

DRUG

GEH200520 Injection / GEH200521 (18F) Injection - Part B

Administration of GEH200520 Injection followed within 2 to 4 minutes by GEH200521 (18F) Injection followed by a 10mL saline flush

DIAGNOSTIC_TEST

Static - PET/CT scan

Whole-body PET/CT scan (up to 30 min). Exact timing will be determined from Part A. An optional dynamic scan may be acquired in addition to the required whole-body PET/CT scan at each imaging visit.

Trial Locations (1)

Unknown

RECRUITING

UMC Groningen, Groningen

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GE Healthcare

INDUSTRY

NCT05629689 - A Study to Evaluate GEH200520/GEH200521 (18F) Safety and Tolerability When Used for PET Scans in Patients With Solid Tumour Malignancies | Biotech Hunter | Biotech Hunter