[F-18] Fluorothymidine PET/CT Imaging for Pelvic Cancers
| Status: | Completed |
|---|---|
| Conditions: | Prostate Cancer, Colorectal Cancer, Cervical Cancer, Cervical Cancer, Women's Studies |
| Therapuetic Areas: | Oncology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/28/2019 |
| Start Date: | October 1, 2012 |
| End Date: | April 30, 2017 |
Improving Pelvic Cancer Patient Chemoradiotherapy Outcomes With FLT PET Imaging
[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.
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.
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.
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.
Inclusion Criteria:
- Ability to understand and willingness to sign a written informed consent document.
- Recommended to undergo pelvic irradiation with concurrent chemotherapy.
- At least 18 years of age. Pediatrics would be best served by a protocol designed for
their specific needs.
- Karnofsky Performance Status of at least 60% at time of screening.
- Life expectancy of greater than 6 months.
- Subject must have normal organ and marrow function (as defined below) within 30 days
of study enrollment:
- leukocytes at least 3,000 / µL
- absolute neutrophil count of at least 1500 / µL
- platelets of at least 100,000 / µL
- creatinine equal to or less than the upper limit of normal
- not pregnant (as applicable)
Exclusion Criteria:
- history of allergic reactions attributed to compounds of similar chemical or biologic
composition to FLT
- an oncology research protocol requiring full pelvic radiation (i.e., 4 field box
technique)
- uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.
- subjects taking nucleoside analog medications such as those used as antiretroviral
agents.
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