Clinical trial · Interventional
MRI-Guided Brachytherapy in Treating Participants With HPV-Associated Stage IB2-IVA Cervical or Stage II-IVA Vaginal Cancer
MRI Guided Brachytherapy for HPV-Associated Cervical and Vaginal Malignancies
NCT03634267CI-TRIAL-00108294terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 16, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260916-000001
Why stopped (as posted): PI Request
Summary
Brief summary (as posted)
This trial studies how well magnetic resonance imaging (MRI)-guided internal radiation therapy (brachytherapy) works in treating participants with human papillomavirus (HPV) associated stage IB2-IV cervical or stage II-IVA vaginal cancer. Using MRI guidance during brachytherapy applicator placement may improve treatment planning in participants with cervical or vaginal cancer.
Conditions
Conditions (17)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Human Papillomavirus-Related Carcinoma | Human Papillomavirus-Related Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Human Papillomavirus-Related Cervical Carcinoma | Human Papillomavirus-Related Cervical Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Stage IB2 Cervical Cancer AJCC v8 | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIA1 Cervical Cancer AJCC v8 | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIA2 Cervical Cancer AJCC v8 | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIA Cervical Cancer AJCC v8 | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIA Vaginal Cancer AJCC v8 | Malignant Vaginal Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Cervical Cancer AJCC v8 | Malignant Cervical Neoplasm |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Internal Radiation Therapy | Radiation | — | UNRESOLVED |
| Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (MRI, internal radiation therapy)
- description
- Participants undergo MRI scan during internal radiation therapy applicator placement.
- interventionNames
- Radiation: Internal Radiation Therapy
- Procedure: Magnetic Resonance Imaging
Primary outcomes (1)
- measure
- Percent of patients achieving high-risk clinical target volume (HR-CTV) dose to 90% (D90)
- timeFrame
- Up to 4 years
- description
- Rate will be compared to conventional guidance, with ultrasound and freehand technique. We will compare the HR-CTV D90 and other secondary dosimetry parameters (e.g. D2 cc bladder, D2 cc rectum etc.) between the initial scan (subsequent to ultrasound \[US\] guided or freehand applicator placement) and optimized (with magnetic resonance imaging \[MRI\] guided placement) treatment plan for each patient using McNemar's test.
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women with stage 1B2-IVA cervical cancer recommended to receive definitive chemoradiation including brachytherapy; or * Women with stage II-IVA vaginal cancer recommended to receive definitive chemoradiation including brachytherapy. Exclusion Criteria: * Patient or tumor anatomy that requires use of a non-MRI-compatible applicator. * Patients with implantable cardioverter-defibrillator, pacemaker or other implanted device or medical condition which precludes MRI acquisition.
References
Publications (0)
Data not yet available
No reference posted for this study.