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FLT PET Imaging for Cervical Cancer

Primary Purpose

Uterine Cervical Neoplasms

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
[F18]Fluorothymidine
Sponsored by
University of Iowa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Cervical Neoplasms focused on measuring Positron-Emission Tomography, Radiotherapy, Intensity-Modulated

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Ability to understand and willingness to sign a written informed consent document.
  • Histologically confirmed stage IB2, IIA, IIB, IIIB, and IVA squamous cell carcinoma of the cervix.
  • Scheduled to receive chemo-radiation for oncologic treatment.
  • Karnofsky of at least 60 at time of screening
  • Life expectancy of at least 6 months.
  • Leukocytes at least 3,000/microL
  • absolute neutrophil count at least 1,500/microL
  • platelets at least 100,000/microL
  • total bilirubin at maximum 1.0 mg/dL (UIHC limit of normal)
  • either ALT or AST less than 2.5 times the upper limit of normal
  • creatinine less than 1.5 times the upper limit of normal
  • non-pregnant, non-nursing, willing to use contraception

Exclusion Criteria:

  • oncology research protocol requiring full pelvic radiation (i.e., 4-field box technique) or experimental chemotherapy
  • 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 the study requirements.
  • subjects taking nucleoside analog medications such as those used as antiretroviral agents.
  • patients who have undergone hysterectomy or will have a hysterectomy as part of their cancer therapy.

Sites / Locations

  • Holden Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 2

Group 1

Arm Description

Receives fourth [F18]Fluorothymidine (FLT) PET scan after 20 fractions of radiation therapy.

Receives fourth [F18]Fluorothymidine (FLT) PET scan after 15 fractions of radiation therapy.

Outcomes

Primary Outcome Measures

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 dose bins 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.

Secondary Outcome Measures

Chemotherapy Compliance
The number of participants who missed at least one prescribed chemotherapy administration due to low blood counts.
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell 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
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
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
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
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.
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
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

Full Information

First Posted
February 23, 2010
Last Updated
October 25, 2017
Sponsor
University of Iowa
Collaborators
Holden Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT01075412
Brief Title
FLT PET Imaging for Cervical Cancer
Official Title
'F-18 Fluorothymidine ([18F]FLT) PET Imaging for Early Evaluation of Response to Chemoradiation Therapy in Patients With Cervical Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Terminated
Why Stopped
Study was closed and reopened as NCT01717391
Study Start Date
September 2009 (Actual)
Primary Completion Date
March 3, 2016 (Actual)
Study Completion Date
April 11, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Iowa
Collaborators
Holden Comprehensive Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Our primary hypothesis is that [18F]FLT PET can identify active bone marrow in addition to metabolically active tumor. This trial will use FLT-PET imaging to define areas of active bone marrow in the pelvis. The radiation plan is then designed to spare that area, in hopes of keeping the bone marrow active during therapy. Bone marrow and tumor activity will be monitored using a sequence of FLT PET scans during the course of chemotherapy and radiation therapy.
Detailed Description
Subjects will undergo a total of up to 5 FLT PET scans. Subjects are randomized between two groups to reduce radiation exposure from the FLT PET scans. If bone marrow activity is not identified in one scan, further scans are cancelled until the 1-month follow up scan. This is not a randomization to compare therapeutic efficacy between two study arms. Data will be pooled for analysis as pre-specified in the study's statistical plan. Group 1 has FLT PET scans pretreatment, after 5 radiation treatments, after 10 radiation treatments, after 15 radiation treatments, and then 1 month after completing radiation therapy. Group 2 has FLT PET scans pretreatment, after 5 radiation treatments, after 10 radiation treatments, after 20 radiation treatments, and then 1 month after completing radiation therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Cervical Neoplasms
Keywords
Positron-Emission Tomography, Radiotherapy, Intensity-Modulated

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 2
Arm Type
Experimental
Arm Description
Receives fourth [F18]Fluorothymidine (FLT) PET scan after 20 fractions of radiation therapy.
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Receives fourth [F18]Fluorothymidine (FLT) PET scan after 15 fractions of radiation therapy.
Intervention Type
Drug
Intervention Name(s)
[F18]Fluorothymidine
Other Intervention Name(s)
FLT
Intervention Description
FLT PET scan 5 mCi (+/- 10%)
Primary Outcome Measure Information:
Title
Percent Difference From Baseline IMRT Plan (%)
Description
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 dose bins 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.
Time Frame
Baseline (pre-treatment)
Secondary Outcome Measure Information:
Title
Chemotherapy Compliance
Description
The number of participants who missed at least one prescribed chemotherapy administration due to low blood counts.
Time Frame
post-treatment
Title
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Description
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
Time Frame
baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment
Title
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Description
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
Time Frame
baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment
Title
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Description
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.
Time Frame
baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment
Title
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Description
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
Time Frame
baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ability to understand and willingness to sign a written informed consent document. Histologically confirmed stage IB2, IIA, IIB, IIIB, and IVA squamous cell carcinoma of the cervix. Scheduled to receive chemo-radiation for oncologic treatment. Karnofsky of at least 60 at time of screening Life expectancy of at least 6 months. Leukocytes at least 3,000/microL absolute neutrophil count at least 1,500/microL platelets at least 100,000/microL total bilirubin at maximum 1.0 mg/dL (UIHC limit of normal) either ALT or AST less than 2.5 times the upper limit of normal creatinine less than 1.5 times the upper limit of normal non-pregnant, non-nursing, willing to use contraception Exclusion Criteria: oncology research protocol requiring full pelvic radiation (i.e., 4-field box technique) or experimental chemotherapy 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 the study requirements. subjects taking nucleoside analog medications such as those used as antiretroviral agents. patients who have undergone hysterectomy or will have a hysterectomy as part of their cancer therapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael M Graham, Ph.D., M.D.
Organizational Affiliation
University of Iowa
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sarah McGuire, Ph.D.
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Holden Comprehensive Cancer Center
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Yes, data will be shared utilizing clinicaltrials.gov results
Citations:
PubMed Identifier
21397965
Citation
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.
Results Reference
background
PubMed Identifier
21300484
Citation
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. Erratum In: Int J Radiat Oncol Biol Phys. 2012 Sep 1;84(1):7.
Results Reference
background
PubMed Identifier
20447554
Citation
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.
Results Reference
background
PubMed Identifier
27319286
Citation
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.
Results Reference
result
PubMed Identifier
25207403
Citation
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.
Results Reference
result

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FLT PET Imaging for Cervical Cancer

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