Neoplasms

Digestive System Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Rectal Neoplasms

Prostatic Neoplasms

Uterine Cervical Neoplasms

Endometrial Neoplasms

Anus Neoplasms

Pelvic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Uterine Neoplasms

Genital Neoplasms, Female

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Anus Diseases

Anal Cancer

Fluorothymidine F 18 (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.

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.

fluorothymidine F 18

John Buatti, PhD

\[F-18\] 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.

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.

[F-18] Fluorothymidine PET/CT Imaging for Pelvic Cancers

Improving Pelvic Cancer Patient Chemoradiotherapy Outcomes With FLT PET Imaging

Data are available upon request. A contract may need to be put into place, dependent upon data shared.

The difference in volume of bone marrow receiving radiation using a bone-marrow-sparing radiation plan compared to a standard radiation plan (IMRT), expressed as a percentage. Both plans are patient-specific. Bone-marrow is identified using the baseline FLT PET/CT obtained pre-imaging. Active bone marrow is considered to have an uptake value (SUV) of 2, 3, or 4. The standard IMRT plan was created using the criteria of the National Cancer Institute's Radiation Therapy Oncology Group study RTOG-0418. Radiation doses evaluated are 5 Gray, 10 Gray, 20 Gray, and 30 Gray. The change in dose to tumor is also provided. A negative value indicates that more bone marrow or tissue was spared using the bone-marrow sparing plan.

The number of participants who had chemotherapy withheld at least once for low blood counts.

White blood cell counts measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured weekly during combined chemotherapy and radiation therapy treatment and then once at 30 day follow-up and at 1 year follow-up

Platelet cell counts measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured once weekly during combined chemotherapy and radiation therapy, then once at 30 day follow-up, and once at 1 year follow-up

Absolute neutrophil counts (ANCs) measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured once weekly during combined chemotherapy and radiation therapy, then once at 30 day follow-up, and once at 1 year follow-up

Lymphocyte counts measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured once weekly during combined chemotherapy and radiation therapy, then once at 30 day follow-up, and once at 1 year follow-up

National Institutes of Health (NIH)

National Cancer Institute (NCI)

John M. Buatti

Professor of Radiation Oncology

Adverse events were collected through medical chart review as well as by direct contact by a licensed health provider with participant for their perceived side effects from the FLT PET/CT scan. Chart review is considered non-systematic collection; the semi-structured interview 48 hours after the scan is considered a systematic collection. Grade 0 is considered no toxicity (symptom is absent) and grade 4 is considered the most severe toxicity.

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.

Fluorothymidine F 18: 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.

FLT PET/CT

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

John M. Buatti, MD

% difference, volume receiving 5 Gray

% difference, volume receiving 10 Gray

% difference, volume receiving 20 Gray

% difference, volume receiving 30 Gray

% difference, dose to target (tumor) volume

FLT PET/CT imaging ordered pre-radiation therapy to create a patient-specific bone marrow map to spare active bone marrow.

Basline FLT PET/CT (All Subjects)

All participants who received an FLT PET/CT during radiation simulation.

Percent Difference From Baseline IMRT Plan (%)

Chemotherapy Compliance

Baseline (pre-treatment)

Therapy, week 1

Therapy, week 2

Therapy, week 3

Therapy, week 4

Therapy, week 5

30 days post-therapy

1 year post-therapy

Participants who have undergone the FLT PET/CT imaging ordered pre-radiation therapy to create a patient-specific bone marrow map to spare active bone marrow.

Bone-marrow Sparing Radiation Therapy (IMRT)

This group includes all tumor types treated in this clinical trial and provides an overall averages.

Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts

Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.

Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)

Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.

Overall Study

Spots Global Cancer Trial Database for fluorothymidine f 18