Clinical trial · Interventional
The Value of Advanced MR Imaging in Gynecological Tumors and Benign Uterine Fibroids
NCT03993210CI-TRIAL-00048592terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Key personnel moving out
Summary
Brief summary (as posted)
This research is being done to test new MRI methods called Magnetic Resonance Fingerprinting and Q-space Trajectory Imaging in gynecological abnormalities. The purpose of this research study is to evaluate if these new MRI methods can give additional information in characterizing gynecological tumors compared with conventional MRI.
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 |
|---|---|---|---|
| Gynecologic Tumor | Female Reproductive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Magnetic Resonance Fingerprinting (MRF) | Device | — | UNRESOLVED |
| Magnetic Resonance Imaging Machine (MRI) | Device | — | UNRESOLVED |
| Q-space Trajectory Imaging (QTI) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- GYN Cancer Cases
- description
- * Confirmed diagnosis of primary or recurrent gynecological (GYN) malignancies. * Routine clinical standard of care pelvic magnetic resonance imaging (MRI) along with advanced techniques Magnetic Resonance Fingerprinting (MRF) and Q-space Trajectory Imaging (QTI) will be performed using a clinical 3T MRI scanner lasting 30-45 minutes with an additional 10-15 minutes for the advanced scans. Per protocol, patient undergoes one scan on visit day 1 and is followed for up to 4 years.
- interventionNames
- Device: Magnetic Resonance Fingerprinting (MRF)
- Device: Q-space Trajectory Imaging (QTI)
- Device: Magnetic Resonance Imaging Machine (MRI)
- type
- ACTIVE_COMPARATOR
- label
- GYN Benign Controls
- description
- * Benign gynecological (GYN) fibroids. * Routine clinical standard of care pelvic magnetic resonance imaging (MRI) along with advanced techniques Magnetic Resonance Fingerprinting (MRF) and Q-space Trajectory Imaging (QTI) will be performed using a clinical 3T MRI scanner lasting 30-45 minutes with an additional 10-15 minutes for the advanced scans. Per protocol, patient undergoes one scan on visit day 1 and is followed for up to 4 years.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants with suspected or histologically confirmed diagnosis of primary or recurrent gynecological cancer including uterine endometrial, cervical, vaginal, vulvar, ovarian, and smooth-muscle tumors undergoing routine clinical standard of care pelvic MRI * Control subjects with benign fibroids undergoing routine clinical standard of care pelvic MRI * Age ≥ 18 years * ECOG performance status of ≤ 2, based on treating physician's discretion (Appendix A) * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Contraindication to MRI identified by the MR procedure screening form, such as a pacemaker, aneurysm clip, inner ear implant, neurostimulator, or other MR non-compatible device or implant * 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 study requirements * Adults unable to consent * Non-english speaking subjects * Pregnant women * Prisoners
References
Publications (0)
Data not yet available
No reference posted for this study.