An Investigation of Tumor Metabolism in Patients Undergoing Surgical Resection

Study ID
STU 062010-157

Cancer Related
Yes

Healthy Volunteers
No

Study Sites

Contact
Sarah McNeil
214-648-5573
sarah.mcneil@utsouthwestern.edu

Principal Investigator
Elizabeth Maher

Summary

This study has been expanded to include subjects with primary tumors outside the central nervous system, inlcuding breast cancer, lung cancer, melanoma, renal cell carcinoma, prostate cancer and colon cancer. Patients with a brain mass identified on brain imaging and who need surgical resection of the mass will be eligible for this metabolism study. eligible study patients will be screened, recruited, and enrolled at uT Southwestern Medical Center in the Harold C. Simmons Comprehensive Cancer Center, university Hospital x Zale Lipshy and university Hospital x St. Paul, Children's Medical Center of Dallas as well as at Parkland Health and Hospital System. We will consent 60 patients, including projected screen failures and early withdrawals, and anticipate that we will study 25 patients in this clinical protocol. once enrolled, patients will undergo a series of pre-operative brain imaging studies including 3T MRi with Diffusion Tensor imaging (DTi) and 1H-MR spectroscopy, 7T MRi and a brain 18FDG-PeT scan within 7-14 days of the scheduled operation. of these studies, only the 3T MRi is standard of care. The DTi and 1H-MR spectroscopy are additional scanning sequences that are being done for research purposes. Similarly, the 7T MRi and the 18FDG-PeT are being done for research purposes only. on the day of surgery, the patient will have a peripheral iV started while waiting in the pre-operative holding area and a 20% solution of either [u-13C]glucose and/or [1,2-13C]acetate (to be determined for each individual patient by the Pi) will be infused at a rate of 4g/hr for a maximum of 4 hours. During the infusion period, 4 timed blood samples will be collected for nMR analysis of 13C-glucose in the blood. The infusion will continue until the tumor has been resected and samples have been collected and flash frozen for 13C-nMR spectral analysis and molecular analyses. The infusion and tumor collection for 13C-nMR analysis is being done for research purposes only. However, the remainder of the neurosurgical operative and post-operative procedures will be followed according to standard practice. The patient will be seen 10-14 days after surgery for a follow up visit at which time an assessment of adverse events will be performed. Thereafter, every 6 months for 5 years or until death, the patient will be contacted and data regarding treatment, responses, and tumor progression will be collected for correlative analysis.

Participant Eligibility


* Male or female, any age and any racial or ethnic origin

* Spanish-speaking patients will be eligible

* Pre-operative brain MR imaging suggestive of a brain tumor or pre-operative imaging showing a tumor or biopsy of a tumor mass prior to planned resection of the mass

* Patient able and willing to provide informed consent or legal parent or guardian willing and able to provide informed consent for patient under age 18.

* Karnofsky Performance status > 70%

* Negative serum pregnancy test or child bearing potential terminated by surgery, radiation, menopause or current use of two approved methods of birth control