Clinical trial · Interventional
FLT PET Imaging for Cervical Cancer
'F-18 Fluorothymidine ([18F]FLT) PET Imaging for Early Evaluation of Response to Chemoradiation Therapy in Patients With Cervical Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study was closed and reopened as NCT01717391
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Cervical Neoplasms | Cervical Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [F18]Fluorothymidine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group 2
- description
- Receives fourth \[F18\]Fluorothymidine (FLT) PET scan after 20 fractions of radiation therapy.
- interventionNames
- Drug: [F18]Fluorothymidine
- type
- EXPERIMENTAL
- label
- Group 1
- description
- Receives fourth \[F18\]Fluorothymidine (FLT) PET scan after 15 fractions of radiation therapy.
- interventionNames
- Drug: [F18]Fluorothymidine
Primary outcomes (1)
- measure
- Percent Difference From Baseline IMRT Plan (%)
- timeFrame
- Baseline (pre-treatment)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (5)
- BACKGROUNDMcGuire 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
- BACKGROUNDMcGuire 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
- BACKGROUNDMenda 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
- RESULTMcGuire 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
- RESULTMcGuire 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