Actively Recruiting
A Study to Evaluate GEH200520/GEH200521 (18F) Safety and Tolerability When Used for PET Scans in Patients With Solid Tumour Malignancies
Led by GE Healthcare · Updated on 2025-11-17
50
Participants Needed
2
Research Sites
319 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Part A: The purpose of this part is to assess the safety of GEH200520 and GEH200521 (18F) when administered to patients with solid cancer. Subjects will be requested to complete 3 study visits: 1 screening visit, 1 imaging visit (over 24 hours) and 1 follow-up visit (7 days later). The estimated duration of Part A is 21 days. Part B: The purpose of this part of the study is to assess the imaging quality and findings as well as the safety and tolerability of GEH200520 and GEH200521 (18F) when administered to patients with cancer before and after immunotherapy treatment. Subjects will be requested to complete 7 study visits: 1 screening visit, the first imaging visit, followed by 2 immunotherapy immune-checkpoint inhibitor (ICI) treatment visits and 2 additional imaging and 1 follow-up visit. Two late imaging transfer expected post follow up visit. The estimated duration for subject participation in Part B is approximately 64 days.
CONDITIONS
Official Title
A Study to Evaluate GEH200520/GEH200521 (18F) Safety and Tolerability When Used for PET Scans in Patients With Solid Tumour Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to follow all study procedures and provide informed consent
- Male or female, 18 years of age or older
- Life expectancy of at least 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Diagnosed with unresectable or metastatic solid tumor, local and resectable head and neck squamous cell carcinoma, or unresectable stage III-IV melanoma
- Eligible for immune-checkpoint inhibitor (ICI) treatment per Investigator judgment
- Has at least 1 measurable tumor lesion documented by CT or MRI in the last 12 months
- Has tumor lesion(s) suitable for safe biopsy according to standard clinical care
- Agrees to follow protocol contraception methods if applicable
You will not qualify if you...
- Unable to undergo or tolerate all study procedures, including staying still during imaging
- Significant abnormal 12-lead ECG findings during screening
- Unstable medical condition or therapy that could compromise safety or study goals
- Active or history of autoimmune disease requiring systemic steroids or immunosuppressive agents
- Serious non-malignant diseases or conditions compromising safety or study goals
- Diagnosis of B or T cell lymphoma
- Brain or bone marrow metastasis compromising safety or study goals
- Signs or symptoms of systemic infection within 2 weeks before imaging
- History of severe allergic or hypersensitivity reactions to chimeric or humanized antibodies, fusion proteins, or study drug ingredients
- Diseases or conditions contraindicating immune-checkpoint inhibitor treatment or affecting study results
- Laboratory values out of protocol-specified range
- Safety laboratory test results compromising safety or study goals
- Major surgery within 4 weeks before enrollment
- Participation in another interventional clinical study within 30 days before screening except study site IIS
- Pregnant, planning pregnancy, or breastfeeding
- History of alcohol or drug abuse within the past year
- Treatment with systemic immunostimulatory agents within 6 weeks or 5 drug half-lives before dosing
- Treatment with systemic immunosuppressive medications within 2 weeks before dosing
- Use of acute low-dose systemic immunosuppressants that could affect study objectives
- Use of systemic corticosteroids to treat inflammatory or autoimmune symptoms
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Amsterdam UMC
Amsterdam, Netherlands
Not Yet Recruiting
2
UMC Groningen
Groningen, Netherlands
Actively Recruiting
Research Team
Y
Yaron Raiter, MD
CONTACT
S
Shoma Das
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
DIAGNOSTIC
Number of Arms
7
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