Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

FLT PET Imaging for Cervical Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Holden Comprehensive Cancer Center
Information provided by (Responsible Party):
Sarah McGuire, University of Iowa
ClinicalTrials.gov Identifier:
NCT01075412
First received: February 23, 2010
Last updated: October 18, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Uterine Cervical Neoplasms
Drug: [F18]Fluorothymidine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: `F-18 Fluorothymidine ([18F]FLT) PET Imaging for Early Evaluation of Response to Chemoradiation Therapy in Patients With Cervical Cancer

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • FLT uptake [ Time Frame: baseline, weeks 1, 2, 3, and 4 of therapy, and 1 month post-therapy ] [ Designated as safety issue: Yes ]
    Standarized uptake values of the FLT tracer signal in both the tumor volume and bone marrow volume. Changes in uptake will be assessed compared to treatment outcome as well as blood cell counts.

  • Prognostic outcome [ Time Frame: Post-treatment ] [ Designated as safety issue: No ]
    Comparing change in the standardized uptake value against local and regional disease control as well as disease free survival.


Secondary Outcome Measures:
  • Bone marrow [ Time Frame: pre-treatment ] [ Designated as safety issue: No ]
    The volume of pelvic bone that will be irradiated and the volume of active bone marrow treated as identified by the baseline FLT PET scan.

  • Biomarkers [ Time Frame: Weekly during treatment ] [ Designated as safety issue: Yes ]
    White blood cell and platelet counts, using pretreatment blood draw as baseline.

  • Compliance [ Time Frame: post-treatment ] [ Designated as safety issue: No ]
    Compliance with planned chemotherapy cycles (the number completed versus the number planned)


Estimated Enrollment: 30
Study Start Date: September 2009
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 2
Receives fourth [F18]Fluorothymidine (FLT) PET scan after 20 fractions of radiation therapy.
Drug: [F18]Fluorothymidine
FLT PET scan 5 mCi (+/- 10%)
Other Name: FLT
Experimental: Group 1
Receives fourth [F18]Fluorothymidine (FLT) PET scan after 15 fractions of radiation therapy.
Drug: [F18]Fluorothymidine
FLT PET scan 5 mCi (+/- 10%)
Other Name: FLT

Detailed Description:

Subjects will undergo a total of 5 FLT PET scans.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01075412

Locations
United States, Iowa
Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Holden Comprehensive Cancer Center
Investigators
Study Director: Michael M Graham, Ph.D., M.D. The University of Iowa
Principal Investigator: Sarah McGuire, Ph.D. The University of Iowa
  More Information

Publications:
Responsible Party: Sarah McGuire, Assistant Professor of Radiation Oncology, University of Iowa
ClinicalTrials.gov Identifier: NCT01075412     History of Changes
Other Study ID Numbers: 200906786
Study First Received: February 23, 2010
Last Updated: October 18, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of Iowa:
Positron-Emission Tomography
Radiotherapy, Intensity-Modulated

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms

ClinicalTrials.gov processed this record on November 27, 2014