Gynecologic TumorNCT03993210
The Value of Advanced MR Imaging in Gynecological Tumors and Benign Uterine Fibroids
A study testing Magnetic Resonance Fingerprinting (MRF), Q-space Trajectory Imaging (QTI) and Magnetic Resonance Imaging Machine (MRI) in people with Gynecologic Tumor, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gynecologic Tumor
- What is being tested?
- Magnetic Resonance Fingerprinting (MRF), Q-space Trajectory Imaging (QTI) and Magnetic Resonance Imaging Machine (MRI)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Sep 2019to 19 Sep 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
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.
Read the 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
- Conditions
- Gynecologic Tumor
- Being tested
- Magnetic Resonance Fingerprinting (MRF), Q-space Trajectory Imaging (QTI), Magnetic Resonance Imaging Machine (MRI)
- Keywords
- Gynecologic Tumor
- Medical subject headings
- Genital Neoplasms, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Fingerprinting (MRF)Device
In MRF, multiple tissue properties are acquired simultaneously.
Q-space Trajectory Imaging (QTI)Device
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.
Magnetic Resonance Imaging Machine (MRI)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| GYN Cancer Cases | Experimental | * 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. Receives: Device: Magnetic Resonance Fingerprinting (MRF); Device: Q-space Trajectory Imaging (QTI); Device: Magnetic Resonance Imaging Machine (MRI) |
| GYN Benign Controls | Active comparator | * 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. Receives: Device: Magnetic Resonance Fingerprinting (MRF); Device: Q-space Trajectory Imaging (QTI); Device: Magnetic Resonance Imaging Machine (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)]
Measured: Day 1
Secondary outcomes (8)
MRF T1 Relaxation Value
T1 relaxation values (unit: milliseconds) will be extracted from regions-of-interest based on anatomical structures using MRF.
Measured: Day 1
MRF T2 Relaxation Value
T2 relaxation values (unit: milliseconds) will be extracted from regions-of-interest based on anatomical structures in using MRF.
Measured: Day 1
QTI Total Mean Kurtosis
Total mean kurtosis evaluated by established methods using QTI
Measured: Day 1
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
Measured: Day 1
QTI Isotropic Heterogeneity MK1
Isotropic heterogeneity MK1 value evaluated by established methods using QTI
Measured: Day 1
QTI Fractional Anisotropy FA
Fractional anisotropy FA value evaluated by established methods using QTI
Measured: Day 1
QTI Microscopic Fractional Anisotropy µFA
Microscopic fractional anisotropy µFA value evaluated by established methods using QTI
Measured: Day 1
Median Overall Survival
Time from enrollment to death or last follow-up (censored) estimated using Kaplan-Meier methods
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start18 Sep 2019
- Primary completion19 Sep 2019
- Study completion19 Sep 2019
Why it stopped: Key personnel moving out
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gynecologic TumorStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clare Tempany, Dana-Farber Cancer Institute
- Investigators
- Clare Tempany, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03993210
- Sponsor's protocol ID
- 19-056
- Status last verified
- Nov 2020
- First submitted
- 22 May 2019
- Last updated
- 2 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Advanced MR Imaging in Gynecological Tumors and Benign Uterine Fibroids
- ClinicalTrials.gov ID
- NCT03993210
- Acronym / sponsor ID
- 19-056
- Conditions
- Gynecologic Tumor
- Keywords
- Gynecologic Tumor
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Key personnel moving out
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 18 Sep 2019 (actual)
- Primary completion
- 19 Sep 2019 (actual)
- Study completion
- 19 Sep 2019 (actual)
- First posted
- 20 Jun 2019 (actual)
- Results
- Posted 2 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GYN Cancer Cases | Experimental | Device: Magnetic Resonance Fingerprinting (MRF), Device: Q-space Trajectory Imaging (QTI), Device: Magnetic Resonance Imaging Machine (MRI)* 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. |
| GYN Benign Controls | Active comparator | Device: Magnetic Resonance Fingerprinting (MRF), Device: Q-space Trajectory Imaging (QTI), Device: Magnetic Resonance Imaging Machine (MRI)* 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance Fingerprinting (MRF)In MRF, multiple tissue properties are acquired simultaneously. | Device | GYN Benign Controls, GYN Cancer Cases |
| Q-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. | Device | GYN Benign Controls, GYN Cancer Cases |
| Magnetic 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. | Device | GYN Benign Controls, GYN Cancer Cases |
Primary outcome
Number of Patients With Feasible Imaging
Time frame: 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)]
8 secondary outcomes
MRF T1 Relaxation Value
Time frame: Day 1
MRF T2 Relaxation Value
Time frame: Day 1
QTI Total Mean Kurtosis
Time frame: Day 1
QTI Microscopic Anisotropy MKA
Time frame: Day 1
QTI Isotropic Heterogeneity MK1
Time frame: Day 1
QTI Fractional Anisotropy FA
Time frame: Day 1
QTI Microscopic Fractional Anisotropy µFA
Time frame: Day 1
Median Overall Survival
Time frame: Up to 4 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clare Tempany, MD principal investigator
Brigham and Women's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Fingerprinting (MRF), Q-space Trajectory Imaging (QTI) and Magnetic Resonance Imaging Machine (MRI) in people with Gynecologic Tumor, run by Dana-Farber Cancer Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Feasible Imaging (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2020.