Gynecologic Tumor
Conditions
Keywords
Gynecologic Tumor
Brief summary
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.
Detailed description
Magnetic resonance imaging (MRI) is a safe and painless test that uses a magnetic field and radio waves to produce detailed images of the body's organs and structures. This research is being done to test new MRI methods called Magnetic Resonance Fingerprinting (MRF) and Q-space Trajectory Imaging (QTI) 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 In this research study, the investigators are: * Investigating the use of MR imaging in gynecological tumors on imaging quality and comparison of tumor or fibroid structures and normal anatomy * Investigating whether new MRI methods could help in characterizing the tumor and give information about the expected outcome
Interventions
DEVICEMagnetic Resonance Fingerprinting (MRF)
In MRF, multiple tissue properties are acquired simultaneously.
DEVICEQ-space Trajectory Imaging (QTI)
By using q-space trajectory encoding and a diffusion tensor distribution model, QTI improves the discrimination of diffusivity, shape, and orientation of diffusion microenvironments and therefore carries major potential for imaging the tumor microenvironment.
DEVICEMagnetic Resonance Imaging Machine (MRI)
MRI is routinely used in gynecologic malignancies for its ability to depict the extent of disease at diagnosis providing guidance in staging and treatment planning.
Sponsors
Dana-Farber Cancer Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Feasible Imaging | Day 1 | Feasibility is determined by both A) having evaluable images in terms of quality according to radiology review and B) having a complete set of tumor metrics \[MRF (T1 and T2 relaxation values) and QTI (total mean kurtosis MKT, microscopic anisotropy MKA, isotropic heterogeneity MK1, fractional anisotropy FA, microscopic fractional anisotropy µFA)\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| QTI Total Mean Kurtosis | Day 1 | Total mean kurtosis evaluated by established methods using QTI |
| MRF T1 Relaxation Value | Day 1 | T1 relaxation values (unit: milliseconds) will be extracted from regions-of-interest based on anatomical structures using MRF. |
| QTI Microscopic Anisotropy MKA | Day 1 | MKa (normalized variance due to anisotropic heterogeneity, unitless) will be extracted from regions-of-interest based on anatomical structures in using advanced diffusion weighted sequences with QTI |
| MRF T2 Relaxation Value | Day 1 | T2 relaxation values (unit: milliseconds) will be extracted from regions-of-interest based on anatomical structures in using MRF. |
| QTI Fractional Anisotropy FA | Day 1 | Fractional anisotropy FA value evaluated by established methods using QTI |
| QTI Microscopic Fractional Anisotropy µFA | Day 1 | Microscopic fractional anisotropy µFA value evaluated by established methods using QTI |
| Median Overall Survival | Up to 4 years | Time from enrollment to death or last follow-up (censored) estimated using Kaplan-Meier methods |
| QTI Isotropic Heterogeneity MK1 | Day 1 | Isotropic heterogeneity MK1 value evaluated by established methods using QTI |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GYN Cancer Cases * 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. | 1 |
| GYN Benign Controls * 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. | 0 |
| Total | 1 |
Baseline characteristics
| Characteristic | GYN Cancer Cases | Total |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 1 Participants |
| Region of Enrollment United States | 1 participants | 1 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Number of Patients With Feasible Imaging
Feasibility is determined by both A) having evaluable images in terms of quality according to radiology review and B) having a complete set of tumor metrics \[MRF (T1 and T2 relaxation values) and QTI (total mean kurtosis MKT, microscopic anisotropy MKA, isotropic heterogeneity MK1, fractional anisotropy FA, microscopic fractional anisotropy µFA)\]
Time frame: Day 1
Population: No analysis was conducted because the PI left the institution. This lead to closure of the study.
Secondary
Median Overall Survival
Time from enrollment to death or last follow-up (censored) estimated using Kaplan-Meier methods
Time frame: Up to 4 years
Population: PI left the country, resulting in study closure.
Secondary
MRF T1 Relaxation Value
T1 relaxation values (unit: milliseconds) will be extracted from regions-of-interest based on anatomical structures using MRF.
Time frame: Day 1
Population: PI left the country, resulting in study closure.
Secondary
MRF T2 Relaxation Value
T2 relaxation values (unit: milliseconds) will be extracted from regions-of-interest based on anatomical structures in using MRF.
Time frame: Day 1
Population: PI left the country, resulting in study closure.
Secondary
QTI Fractional Anisotropy FA
Fractional anisotropy FA value evaluated by established methods using QTI
Time frame: Day 1
Population: PI left the country, resulting in study closure.
Secondary
QTI Isotropic Heterogeneity MK1
Isotropic heterogeneity MK1 value evaluated by established methods using QTI
Time frame: Day 1
Population: PI left the country, resulting in study closure.
Secondary
QTI Microscopic Anisotropy MKA
MKa (normalized variance due to anisotropic heterogeneity, unitless) will be extracted from regions-of-interest based on anatomical structures in using advanced diffusion weighted sequences with QTI
Time frame: Day 1
Population: PI left the country, resulting in study closure.
Secondary
QTI Microscopic Fractional Anisotropy µFA
Microscopic fractional anisotropy µFA value evaluated by established methods using QTI
Time frame: Day 1
Population: PI left the country, resulting in study closure.
Secondary
QTI Total Mean Kurtosis
Total mean kurtosis evaluated by established methods using QTI
Time frame: Day 1
Population: PI left the country, resulting in study closure.