Clinical trial · Interventional
Magnetic Resonance Imaging Guided Gynecologic Brachytherapy
Pilot Study of Magnetic Resonance Imaging Guided Brachytherapy
- 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)
The primary goal of this pilot study is to assess the feasibility of using magnetic resonance (MR) imaging guidance in the Magnetic Resonance Therapy (MRT) unit at the Brigham and Women's Hospital during the implantation of brachytherapy applicators in patients with gynecologic malignancies. Patients with gynecologic malignancies requiring brachytherapy are currently treated under either fluoroscopic or CT visualization of the brachytherapy applicator. Magnetic resonance imaging has been shown in many studies to provide superior visualization of the cervix, vagina and uterus compared to CT. However no prior study has examined the feasibility of using real-time magnetic resonance imaging to assist in the guidance of gynecologic brachytherapy applicators
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervix Neoplasms | Cervical Neoplasm | ALIAS | 0.90 |
| Uterine Neoplasms | Uterine Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Vaginal Neoplasms | Vaginal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Vulvar Neoplasms | Vulvar Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brachytherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Insertion of needles into the bladder or rectum
Secondary outcomes (3)
- measure
- Ability of MR imaging to accurately determine tumor, bladder and rectal volumes
- measure
- Assessment of acute skin, genitourinary and gastrointestinal toxicities
- measure
- Assessment of tumor progression or recurrence during a 180 day follow-up period
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic documentation of carcinoma. Carcinoma of the cervix: Stage IIIB, IVA or vaginal recurrence * Carcinoma of the cervix: Stage IB, IIA, IIB or IIIA with obliteration of the cervical os (tandem and ovoid implant not feasible) * Carcinoma of the uterus: Stage IIIB (vaginal involvement) or vaginal recurrence * Carcinoma of the vagina: Stage II, III, IVA or vaginal recurrence * Carcinoma of the vulva: T3 (vaginal extension) or T4 (inoperable - any N stage), or vaginal recurrence * MRI and CT of the pelvis within 2 months before registration * ECOG performance status of \< 2 * Age \> 18 * Signed informed consent * No metallic objects or pacemakers in the patient * Negative pregnancy test for those of child-bearing potential * Patients who have received prior radiation or chemotherapy may be enrolled on this study. * Documented complete blood count (CBC) with hematocrit (Hct)\>30, absolute neutrophil count (ANC)\>500, platelet (Plt) \>40 Exclusion Criteria: * Patients with distant metastasis. * Baseline studies not obtained. * Patients who are pregnant or lactating. * Significant history of cardiovascular disease.
References
Publications (0)
Data not yet available