[F-18] Fluorothymidine PET/CT Imaging for Pelvic Cancers
[F-18] Fluorothymidine PET imaging will be used to create a radiation therapy treatment plan to avoid active bone marrow in the pelvis. This will be done to evaluate if sparing bone marrow will help maintain blood counts. This would impact chemotherapy administration.
Uterine Cervical Neoplasms
Radiation: Bone marrow sparing IMRT radiation therapy
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Improving Pelvic Cancer Patient Chemoradiotherapy Outcomes With FLT PET Imaging|
- Changes in FLT uptake as measured by PET/CT scanning [ Time Frame: baseline, weeks 1 and 2 of therapy, 1 month post radiation therapy, and 1 year post radiation therapy ] [ Designated as safety issue: No ]Standardized uptake values of the FLT tracer signal in pelvic bone marrow will be used to create patient-specific bone marrow spatial maps to reduce bone marrow dose during radiation therapy planning. Changes in uptake will be assessed in relation to the radiation therapy plan.
- Adverse event frequency [ Time Frame: weekly during radiation treatment treatment for up to 8 weeks; then at 1 month, 3 months and 1 year post-radiation ] [ Designated as safety issue: No ]Assess grade 2 and higher adverse events. Evaluate the relationship between radiation dose, the bone marrow spatial map, and the adverse event frequency and profile.
- Blood Cell Counts [ Time Frame: baseline, weekly during radiation treatment for up to 8 weeks, 30 days and 1 year after treatment ] [ Designated as safety issue: No ]Blood counts will be recorded to assess the effect of radiation dose on pelvic bone marrow activity.
- Chemotherapy compliance [ Time Frame: At 24 months ] [ Designated as safety issue: No ]The amount of chemotherapy administered will be compared to the amount of chemotherapy prescribed. A secondary comparison against the level of bone marrow suppression (as measured by both the blood cell counts and FLT PET/CT scans) may also be performed. This cannot be assessed until the participant has completed their entire prescribed course of chemotherapy, which will vary based on their tumor type.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: FLT PET/CT
FLT PET/CT imaging ordered pre-radiation therapy, during weeks 1 and 2 of radiation therapy, and then at 1 month and 12 months after radiation therapy. The FLT PET/CT imaging ordered pre-radiation therapy is used for bone marrow sparing IMRT radiation therapy.
Radiation: Bone marrow sparing IMRT radiation therapy
A patient-specific bone marrow map will be designed from the pre-therapy FLT PET/CT imaging. A highly conformal radiation plan will be designed to spare active bone marrow.
Overall survival of pelvic cancer patients depends on control of systemic disease. If local radiation therapy depletes bone marrow function to such an extent that systemic therapies must be withheld, chances of metastatic failure increase significantly. This may be more significant for this group of patients because approximately one third of adult bone marrow is located in the pelvic region. Strategies to minimize toxicities would benefit a range of pelvic cancer patients including gynecologic, anal, rectal, and prostate. New chemoradiation combinations improve outcomes for these disease sites, but come at the cost of higher levels of toxicity. As many as 40% of cervical cancer patients miss at least one chemotherapy cycle due to hematologic toxicity and 36% of anal cancer patients experience grade 3 or 4 hematologic toxicity when undergoing chemoradiation therapy. A clinical trial of concurrent chemoradiation therapy for rectal cancer was terminated due to toxicity, including hematologic toxicities. Concurrent chemoradiation therapy shows promise for advanced stage prostate cancers, but it also increases grade 3 and 4 toxicities. To successfully limit hematologic toxicities for pelvic cancers, it is extremely advantageous to avoid irradiating the highly proliferative compartments of the pelvic bone marrow. However, the complex structure of the pelvis makes it difficult to assess the efficacy of radiation therapy (RT) planning strategies to avoid areas critical to hematopoiesis. Uptake of [18F]fluorothymidine imaged with positron emission tomography (FLT PET/CT) can be an accurate and sensitive tool for identifying and monitoring the effects of chemoradiation on proliferative pelvic bone marrow. Clinically validating the utility of FLT PET/CT imaging for identifying active bone marrow in the design of bone marrow sparing RT-plans and the important bone marrow assessment time points would provide a method to reduce acute and chronic hematologic toxicities for pelvic cancer patients.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01717391
|Contact: Sandy Vollstedt, RN, BSN, OCN||(319) firstname.lastname@example.org|
|Contact: Heather Brown, RN, BAN, OCN||(319) email@example.com|
|United States, Iowa|
|Holden Comprehensive Cancer Center||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: Sandy Vollstedt, RN, BSN 319-353-7143 firstname.lastname@example.org|
|Contact: Jane Hershberger, RN, BSN (319) 384-7912 email@example.com|
|Sub-Investigator: Sudershan K Bhatia, MD, MPH, PhD|
|Sub-Investigator: Michael Goodheart, MD|
|Sub-Investigator: Yusuf Menda, MD|
|Sub-Investigator: John Sunderland, PhD|
|Sub-Investigator: John Bayouth, PhD|
|Sub-Investigator: Michael Graham, PhD, MD|
|Sub-Investigator: Laura Ponto, PhD|
|Sub-Investigator: David Dick, PhD|
|Sub-Investigator: Brandie Gross, BS, CMD|
|Sub-Investigator: Darrin Pelland, RT(T), CMD|
|Sub-Investigator: John Buatti, MD|
|Sub-Investigator: Mark Smith, MD|
|Sub-Investigator: Carryn Anderson, MD|
|Sub-Investigator: Wenqing Sun, MD, PhD|
|Sub-Investigator: Yusung Kim, PhD|
|Sub-Investigator: William Rockey, MD, PhD|
|Sub-Investigator: Perrin McNeely, MD|
|Sub-Investigator: David Bushnell, MD|
|Sub-Investigator: Dean Clermont, CNMT|
|Sub-Investigator: Kellie Bodeker, MSHS, CCRC|
|Sub-Investigator: Shannon Lehman|
|Principal Investigator:||Sarah McGuire, PhD||Department of Radiation Oncology, The University of Iowa|