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 @ 9:54 PM
Ignite Modification Date:
2025-12-24 @ 9:54 PM
NCT ID:
NCT05048732
Eligibility Criteria:
Inclusion Criteria (Healthy Volunteers):
* Adult 18 years of age or older
* No known hematological disorders
* Considered healthy based on assessment by Principal Investigator (PI).
* Able to provide informed consent
* Able to comprehend and willing to follow instructions for study procedures as called for by the protocol.
* Capable of lying still and supine within the PET/CT scanner for up to 1 hour at a time.
Exclusion Criteria (Healthy Volunteers):
* No illicit drug use or other inhaled drug use (including pharmacologic agents, recreational agents or illicit drugs) within the past year per self-reporting mechanisms.
* No history of claustrophobia or other preventing condition that has previously or would interfere with completion of protocol specified imaging sessions.
* Not currently pregnant or nursing: Subject must be surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (cessation of menses for more than 1 year), non-lactating, OR of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of 18 F-FAT) is negative
Inclusion Criteria (Participants with Diffuse Large B Cell Lymphoma):
* Men or women 18 years of age or older with a new diagnosis of lymphoma who will be treated with standard of care therapy for curative intent and at least one measurable (RECIST 1.1), FDG-avid lesion. OR recurrent DLBLC with at least one measurable (RECIST 1.1) FDA-avid lesion and a minimum of 12 months since last receiving treatment.
* If applicable at least one FDG avid lesion accessible for biopsy (ultrasound guided preferred)
* Able to provide informed consent
* Able to tolerate standard of care systemic therapy as recommended by referring physician(s).
Exclusion Criteria (Participants with Diffuse Large B Cell Lymphoma):
* Not currently pregnant or nursing: Subject must be surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (cessation of menses for more than 1 year), non-lactating, OR of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of 18 F-FAT) is negative
* Not currently enrolled in another study using an investigational drug
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05048732
Study Brief:
Protocol Section:
NCT05048732