FLT PET Imaging for Cervical Cancer

Uterine Cervical Neoplasms Clinical Trial

Official title:

`F-18 Fluorothymidine ([18F]FLT) PET Imaging for Early Evaluation of Response to Chemoradiation Therapy in Patients With Cervical Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01075412
• Other study ID #: 200906786
• Status: Terminated
• Phase: Phase 2
• First received: February 23, 2010
• Last updated: October 25, 2017
• Start date: September 2009
• Est. completion date: April 11, 2016

Study information

• Verified date: October 2017
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: April 11, 2016
• Est. primary completion date: March 3, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Uterine Cervical Neoplasms

Intervention

Drug:
• [F18]Fluorothymidine
FLT PET scan 5 mCi (+/- 10%)

Locations

Country	Name	City	State
United States	Holden Comprehensive Cancer Center	Iowa City	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
University of Iowa	Holden Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

References & Publications (5)

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 Che — View Citation

McGuire SM, Menda Y, Boles Ponto LL, Gross B, Buatti J, Bayouth JE. 3'-deoxy-3'-[¹8F]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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Chemotherapy Compliance	The number of participants who missed at least one prescribed chemotherapy administration due to low blood counts.	post-treatment
Secondary	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	baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment
Secondary	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	baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment
Secondary	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.	baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment
Secondary	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	baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment