Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT04721756
Eligibility Criteria:
Inclusion Criteria (Cohort 1):
* At least one imageable tumor greater than or equal to 15 mm in the longest diameter
* Confirmed diagnosis of cancer with a high likelihood of response to immuno-oncology therapy (melanoma or non-small cell lung cancer, or other malignancies with sponsor approval) and planned mono- or combination therapy with immuno-oncology therapy
* Life expectancy of greater than 6 months
Inclusion Criteria (Cohort 2):
* At least one imageable tumor greater than or equal to 15 mm in the longest diameter or a tumor assessable by PET in the opinion of the radiologist
* Received treatment with an immune checkpoint inhibitor with evidence of response
* Life expectancy of greater than 6 months
Exclusion Criteria:
* Subjects who plan to receive chemotherapy or radiation therapy during study participation
* Prior history of failed immune checkpoint inhibitor therapy
* Subjects who require steroid or other immunosuppressive medications within 2 weeks of the PET scan.
* Females of childbearing potential who are not surgically sterile, not refraining from sexual activity, or not using effective methods of contraception. Females of childbearing potential must not be pregnant or breastfeeding at screening and agree to avoid becoming pregnant for 24 hours following study drug administration.
* Females and males must agree to refrain from sexual activity or to use effective contraceptive methods for 24 hours following study drug administration and during study participation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04721756
Study Brief:
Protocol Section:
NCT04721756