- Ages Eligible for Study
- 18 years and up
- Genders Eligible for Study
- National Comprehensive Cancer Network
- University of Utah
- Patients must be 18 years or older for inclusion in this study. Since there is no
experience with [F-18]FLT in children and it would be inappropriate to study
individuals under the age of 18 until more safety data is available.
- After entry into the study, patients are expected to be followed for at least 2
months as part of standard of care.
- All patients, or their legal guardians, must sign a written informed consent and
HIPAA authorization in accordance with institutional guidelines.
- The patient, if female, must be postmenopausal for a minimum of one year or
surgically sterile, or on one of the following methods of birth control for a
minimum of one month prior to entry into this study: IUD, oral contraceptives,
Depo-Provera or Norplant. These criteria can be waived at the discretion of the
investigator if the patient's tumor is considered life threatening and the one
month wait required is not in the best interest of the patient. Negative
pregnancy test is accepted.
- Pre-treatment laboratory tests for patients receiving [F-18]FLT must be
performed within 21 days prior to study entry. These must be less than 4 times
below or above the upper or lower limit range for the respective laboratory
test. These will include liver enzymes (SGOT, SGPT, ALK Phos, GGT, LDH),
bilirubin (direct and total), amylase, serum electrolytes, CBC with platelets
and absolute neutrophil counts, prothrombin time, partial thromboplastin time,
BUN, creatinine, and urinalysis.
- Pre-treatment radiological clinical scans/studies (Gd- enhanced MRI or CT
to document metastatic renal cell carcinoma) must be performed within 30
days of study entry.
- Presence of any ferromagnetic metallic implants or foreign bodies, including
pacemakers and certain types of stents and orthopedic hardware.
- Claustrophobia or inability to remain stationary within MRI system for ~30-45
- Inability to breath hold for periods of at least 20 seconds.
- Known history of adverse reaction to Gd chelate contrast agents.
- Pregnancy or breastfeeding.
- Non-imageable tumor, including tumors with smallest dimension less than 10mm or
tumors located in regions excessively affected by susceptibility artifacts at bone-
and air-tissue interfaces or motion artifacts due to peristalsis or pulsatile flow.
This exploratory clinical study is designed to obtain pre-therapeutic imaging assessments in 20 evaluable patients with metastatic renal cell cancer (RCC) and an early post therapy assessment at baseline and at various early time points (1 week in 5 patients, 2 weeks in 5 patients, 3 weeks in 5 patients and 4 weeks in 5 patients) after institution of standard approved sunitinib therapy at 37.5 mg/day. The clinical imaging biomarkers will include an assessment of tumor metabolism [Bannasch 1986, Frauwirth 2002, Garber 2006, Kelloff 2005, Pauwels 1998, Semenza 2001, Smith 1999, Smith 2000, Sokoloff 1977, Warburg 1956, Weber 1977A, Weber 1977B] (dynamic FDG-PET); tumor proliferation [Rasey 2002,Shields 2001, Shields 1998, Vesselle 2002, Schwartz 2003] (dynamic FLT-PET); tumor blood flow (H215O-PET, DCE MRI)[Lodge 2000], tumor perfusion (DCE-MRI)[Tofts 1999, Tofts 1997, Parker 1999]; and tumor blood volume (H215O-PET, DCE MRI)[Lodge 2000, Tofts 1999, Tofts 1997] in the same patient at baseline and then in the same patient at one of the post therapy time points (1 week, 2 weeks, 3 weeks or 4 weeks). We hypothesize that by using this set of imaging assessments it will be possible to determine an individual or more likely a set of imaging derived biomarkers that will accomplish several of the goals of the initiative which is providing funding for the study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00694096