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

Launched by GE HEALTHCARE · Nov 17, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at two new substances, GEH200520 and GEH200521, which are used in a type of imaging called PET scans. These scans help doctors see what's happening inside the body, especially for patients with solid tumors, or malignant cancers. The study is divided into two parts. In the first part, researchers want to find out if these substances are safe to use in patients with cancer. Participants will attend three visits over about three weeks. The second part will focus on how well the imaging works, especially before and after a specific cancer treatment called immunotherapy. This part involves more visits, totaling about two months.

To participate in this trial, patients must be 18 years or older and have a serious but treatable cancer. They should also be able to follow the study’s instructions and have a good overall health status. The trial is currently looking for volunteers, and it is important for potential participants to be aware of the requirements, such as agreeing to certain contraceptive measures and being stable enough to undergo the imaging procedures. Overall, this study aims to ensure the safety of these imaging substances while helping improve the care of cancer patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • The subject is able and willing to comply with all study procedures as described in the protocol, including the imaging day pre-visit requirements, and has read, signed, and dated an informed consent form prior to any study procedures being performed.
• • The subject is male or female, ≥18 years of age.
• • Subject has a life expectancy ≥12 weeks.
• • Subject has Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• • Subject has an irresectable or metastatic solid tumour or a local and resectable head and neck squamous cell carcinoma.
• • Subject is eligible for ICI treatment.
• • Subject is male, or a female who agrees to comply with the protocol contraception method.
• Exclusion Criteria:
• • Subject is unable to undergo all procedures in the study and/or is unable to remain still and tolerate the imaging procedure.
• • Subject has 12-lead ECG significant findings during screening, per Investigator's assessment.
• • Subject is not stable due to medical condition or therapy that, in the opinion of the Investigator, could compromise subject safety or protocol objectives.
• • Subject has active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents.
• • Subject has any safety laboratory test results (clinical chemistry, haematology, and urinalysis) that, in the opinion of the Investigator, could compromise subject safety or protocol objectives.
• • Subject is pregnant or planning to become pregnant or is lactating.
• • Subject has a history of alcohol or drug abuse within the last year.