FLT PET Imaging for Cervical Cancer

NCT01075412 | Terminated Phase 2 Results DMC

• 1 other identifier: 200906786
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Uterine Cervical Neoplasms

Keywords

Positron-Emission Tomography; Radiotherapy, Intensity-Modulated

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 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.

  Baseline (pre-treatment)

Secondary Outcomes (5)

• Chemotherapy Compliance

  post-treatment

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

  baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment

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

  baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post 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, and 30 days post treatment

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

  baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment

Study Arms (2)

Group 2

EXPERIMENTAL

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

Drug: [F18]Fluorothymidine

Group 1

EXPERIMENTAL

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

Drug: [F18]Fluorothymidine

Interventions

[F18]Fluorothymidine DRUG

FLT PET scan 5 mCi (+/- 10%)

Also known as: FLT

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Iowa: lead
• Holden Comprehensive Cancer Center: collaborator

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: 21397965 BACKGROUND

• 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: 21300484 BACKGROUND

• 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: 20447554 BACKGROUND

• 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: 27319286 RESULT

• 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: 25207403 RESULT

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Limitations and Caveats

The results of this pilot study were merged with NCT01717391 for analysis and resultant publication.

Results Point of Contact

• Title: Sarah McGuire, PhD
• Organization: The University of Iowa

Sarah.McGuire@utsouthwestern.edu

214-645-7613

Study Officials

• Michael M Graham, Ph.D., M.D.

  University of Iowa

  STUDY DIRECTOR

• Sarah McGuire, Ph.D.

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Radiation Oncology

Study Record Dates

• First Submitted: February 23, 2010
• First Posted: February 25, 2010
• Study Start: September 1, 2009
• Primary Completion: March 3, 2016
• Study Completion: April 11, 2016
• Last Updated: December 2, 2017
• Results First Posted: December 2, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)