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 @ 7:13 PM
Ignite Modification Date:
2025-12-24 @ 7:13 PM
NCT ID:
NCT01665703
Eligibility Criteria:
Inclusion Criteria:
* ≥ 18 years of age (no upper age limit)
* Informed consent obtained and signed
* Clinically suspected RCC based on imaging performed prior to enrollment
* Planned nephrectomy schedule that can accommodate a MR-FDG-PET scan within 4 weeks prior to surgery
* Willing to undergo gadolinium enhanced MRI with simultaneous acquisition of FDG-PET uptake by the tumor within 4 weeks prior to nephrectomy
* Willing to consent for genetic and proteomic analysis of tumor and germline nucleic acids
* Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to FDG-PET-MRI
* Breast feeding women cannot do so for 24 hours after FDG injection
* Patient is willing to fast for 4 hours, including avoiding any sugar-containing drinks.
* Patient is willing to drink at least 32 ounces of water (or other no-sugar-containing fluids) within 4 hours prior to arriving for scans.
Exclusion Criteria:
* History of severe reaction to gadolinium-enhanced MRI
* Poorly controlled diabetes mellitus
* Inability to tolerate PET and/or MRI
* Presence of pacemaker or intracranial aneurysm clip
* GFR \< 30mL/min as measured via Cockcroft-Gault equation
* Inability to lie flat for \>1 hour
* Pregnant female
* History of a prior malignancy within past 5 years are excluded unless they have been disease free for 3 or more years or unless they have a completely resected non-melanoma skin cancer, low risk prostate cancer, or other low risk tumor history at the discretion of the investigator.
* Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01665703
Study Brief:
Protocol Section:
NCT01665703