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

March 18, 2019 updated by: John M. Buatti

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Holden Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fluorothymidine F 18 PET/CT
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.
Drug: 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.
Other Names:
  • [F-18] Fluorothymidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Difference From Baseline IMRT Plan (%)
Time Frame: Baseline (pre-treatment)
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.
Baseline (pre-treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chemotherapy Compliance
Time Frame: At 24 months
The number of participants who had chemotherapy withheld at least once for low blood counts.
At 24 months
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Time Frame: baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after treatment
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
baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after treatment
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Time Frame: baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after treatment
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
baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after treatment
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Time Frame: baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after treatment
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
baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after treatment
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Time Frame: baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after treatment
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
baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

John M. Buatti

Collaborators

National Cancer Institute (NCI)
National Institutes of Health (NIH)

Investigators

  • Principal Investigator: John Buatti, PhD, Department of Radiation Oncology, The University of Iowa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

February 29, 2016

Study Completion (Actual)

April 30, 2017

Study Registration Dates

First Submitted

October 18, 2012

First Submitted That Met QC Criteria

October 25, 2012

First Posted (Estimate)

October 30, 2012

Study Record Updates

Last Update Posted (Actual)

March 26, 2019

Last Update Submitted That Met QC Criteria

March 18, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201204712
  • R01CA169336 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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

IPD Sharing Time Frame

Upon request

IPD Sharing Access Criteria

Email the principal investigator for access.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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