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:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-25 @ 1:44 AM
NCT ID:
NCT02599194
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent
* Able to complete a PET/CT scan without the use of sedation
* Females:
* Of childbearing potential must:
* Not be nursing
* Have a negative serum pregnancy test documented within 48 hours prior to administration of 18F FSPG PET/CT
* Not of childbearing potential must be:
* Physiologically postmenopausal (cessation of menses for more than 1 year)
* Surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy)
* Histologically confirmed cancer that is advanced; metastatic; or otherwise not suitable for surgical resection with curative intent
* Scheduled to begin therapy
* The time interval between 18F FSPG PET/CT and standard of care imaging (ie, 18F FDG PET/CT, diagnostic CT, or MRI) should be within 4 weeks (exceptions will be allowed for 6 weeks, if there are no other options)
* Ideally, there should be no chemotherapy, radiotherapy, or immune/biologic therapy or biopsy between other imaging (PET/CTs, MRI, or diagnostic CTs) and 18F FSPG PET/CT scheduled or performed (exceptions by investigator discretion)
* No clinically relevant deviations in renal function (serum creatinine \> grade 2 Common Terminology Criteria for Adverse Events \[CTCAE\] version 4.0); maximal interval between confirmation of renal function and injection of 18F FSPG is 1 week
Exclusion Criteria:
* Scheduled for surgery and/or another invasive procedure (except biopsy) within the time period of 1 month prior to 18F FSPG administration
* Known sensitivity to 18F FSPG or components of the preparation
* Investigator precludes participation for scientific reasons, for reasons of compliance, or for reasons of the patient's safety
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02599194
Study Brief:
Protocol Section:
NCT02599194