NCT01717391

Brief Summary

\[F-18\] 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2012

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

October 18, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 30, 2012

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2016

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2017

Completed
4 months until next milestone

Results Posted

Study results publicly available

September 5, 2017

Completed
Last Updated

March 26, 2019

Status Verified

March 1, 2019

Enrollment Period

3.4 years

First QC Date

October 18, 2012

Results QC Date

June 30, 2017

Last Update Submit

March 18, 2019

Conditions

Uterine Cervical NeoplasmsEndometrial NeoplasmsAnus NeoplasmsRectal NeoplasmsProstatic Neoplasms

Keywords

radiotherapyPositron-Emission Tomography and Computed Tomographychemotherapybone marrow

Outcome Measures

Primary Outcomes (1)

  • Percent Difference From Baseline IMRT Plan (%)

    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 Outcomes (5)

  • Chemotherapy Compliance

    At 24 months

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

    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.

    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)

    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.

    baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after treatment

Study Arms (1)

Fluorothymidine F 18 PET/CT

EXPERIMENTAL

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

Interventions

fluorothymidine F 18DRUG

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.

Also known as: [F-18] Fluorothymidine
Fluorothymidine F 18 PET/CT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States

Location

Related Publications (5)

  • McGuire SM, Menda Y, Ponto LL, Gross B, Juweid M, Bayouth JE. A methodology for incorporating functional bone marrow sparing in IMRT planning for pelvic radiation therapy. Radiother Oncol. 2011 Apr;99(1):49-54. doi: 10.1016/j.radonc.2011.01.025. Epub 2011 Mar 22.

    PMID: 21397965BACKGROUND

  • McGuire SM, Menda Y, Boles Ponto LL, Gross B, Buatti J, Bayouth JE. 3'-deoxy-3'-[(1)(8)F]fluorothymidine PET quantification of bone marrow response to radiation dose. Int J Radiat Oncol Biol Phys. 2011 Nov 1;81(3):888-93. doi: 10.1016/j.ijrobp.2010.12.009. Epub 2011 Feb 6.

    PMID: 21300484BACKGROUND

  • Menda Y, Ponto LL, Dornfeld KJ, Tewson TJ, Watkins GL, Gupta AK, Anderson C, McGuire S, Schultz MK, Sunderland JJ, Graham MM, Buatti JM. Investigation of the pharmacokinetics of 3'-deoxy-3'-[18F]fluorothymidine uptake in the bone marrow before and early after initiation of chemoradiation therapy in head and neck cancer. Nucl Med Biol. 2010 May;37(4):433-8. doi: 10.1016/j.nucmedbio.2010.02.005.

    PMID: 20447554BACKGROUND

  • McGuire SM, Bhatia SK, Sun W, Jacobson GM, Menda Y, Ponto LL, Smith BJ, Gross BA, Bayouth JE, Sunderland JJ, Graham MM, Buatti JM. Using [(18)F]Fluorothymidine Imaged With Positron Emission Tomography to Quantify and Reduce Hematologic Toxicity Due to Chemoradiation Therapy for Pelvic Cancer Patients. Int J Radiat Oncol Biol Phys. 2016 Sep 1;96(1):228-39. doi: 10.1016/j.ijrobp.2016.04.009. Epub 2016 Apr 19.

    PMID: 27319286RESULT

  • McGuire SM, Menda Y, Ponto LLB, Gross B, TenNapel M, Smith BJ, Bayouth JE. Spatial mapping of functional pelvic bone marrow using FLT PET. J Appl Clin Med Phys. 2014 Jul 8;15(4):129-136. doi: 10.1120/jacmp.v15i4.4780.

    PMID: 25207403RESULT

MeSH Terms

Conditions

Uterine Cervical NeoplasmsEndometrial NeoplasmsAnus NeoplasmsRectal NeoplasmsProstatic Neoplasms

Interventions

alovudine

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesAnus DiseasesRectal DiseasesGenital Neoplasms, MaleGenital Diseases, MaleProstatic DiseasesMale Urogenital Diseases

Results Point of Contact

Title
John M. Buatti, MD
Organization
The University of Iowa
john-buatti@uiowa.edu
319-356-2699

Study Officials

  • John Buatti, PhD

    Department of Radiation Oncology, The University of Iowa

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Radiation Oncology

Study Record Dates

First Submitted

October 18, 2012

First Posted

October 30, 2012

Study Start

October 1, 2012

Primary Completion

February 29, 2016

Study Completion

April 30, 2017

Last Updated

March 26, 2019

Results First Posted

September 5, 2017

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Upon request
Access Criteria
Email the principal investigator for access.

Locations

US(1)