Clinical trial · Observational
Hybrid PET/MR in the Therapy of Cervical Cancer
Hybrid PET/MR in the Therapy of Cervical Cancer: A Pilot Study
NCT01759355CI-TRIAL-00055357completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a two arm, single center feasibility study of 20 patients with non-metastatic cervical cancer managed with surgery and/or chemoradiation therapy at UNC Hospitals. Subjects will undergo PET/MRI scans before, during (chemoradiation group only), and after treatment.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Adenosquamous Carcinoma | Cervical Adenosquamous Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Cervical Squamous Cell Carcinoma | Cervical Squamous Cell Carcinoma | CURATED_BROADER | 0.80 |
| Cervix Carcinoma | Cervical Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FDG PET/MR | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Surgery
- description
- Participants undergoing surgical intervention will receive a PET/MR scan prior and following surgery for a total of two (2) scans.
- interventionNames
- Procedure: FDG PET/MR
- label
- Chemoradiation
- description
- Participants undergoing chemoradiation intervention will receive a PET/MR scan prior, during, and following chemoradiation for a total of three (3) scans.
- interventionNames
- Procedure: FDG PET/MR
Primary outcomes (1)
- measure
- Proportion of patients who successfully complete PET/MR scans at all study time-points
- timeFrame
- 2-3 months post-treatment
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ≥ 18 years of age * Biopsy-proven, previously untreated squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the uterine cervix * Clinically visible lesion at least FIGO stage Ib or AJCC 7th edition T1b * Scheduled to undergo standard of care PET/CT for baseline assessment of disease * Anticipated to be eligible for curative intent therapy (surgery of chemoradiation therapy) as determined by the patient's primary oncologist * If female of child-bearing potential, negative serum or urine pregnancy test ≤ 7 dats prior to first PET/MRI * Informed consent reviewed and signed Exclusion Criteria: * History of sever reaction to contrast-enhanced CT scan * Inability to tolerate MRI (e.g., inability to lie flat \> 1 hour) * Presence of pacemaker, intracranial aneurysm clip, bladder stimulator, cochlear implant or metal near eyes * Poorly controlled diabetes mellitus * Creatinine \> 1.4 mg/dL or GFR \< 30 mL/min * Body Mass Index (BMI) \> 35 * Active vaginal bleeding requiring packing and emergent radiation therapy * Pregnant or lactating female * History of a prior malignancy within past 5 years, unless disease free for ≥ 3 years * Substance abuse, medical, psychological, or social conditions that may interfere with study participation
References
Publications (0)
Data not yet available
No reference posted for this study.