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Key personnel moving out
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GYN Cancer Cases | Experimental |
|
|
| GYN Benign Controls | Active Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Resonance Fingerprinting (MRF) | Device | In MRF, multiple tissue properties are acquired simultaneously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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)] | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| MRF T1 Relaxation Value | T1 relaxation values (unit: milliseconds) will be extracted from regions-of-interest based on anatomical structures using MRF. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clare Tempany, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States | ||
| Dana Farber Cancer Institute |
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
Data can be shared no earlier than 1 year following the date of publication.
BCH - Contact the Technology & Innovation Development Office at www.childrensinnovations.org or email TIDO@childrens.harvard.edu BIDMC - Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu BWH - Contact the Partners Innovations team at http://www.partners.org/innovation DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu MGH - Contact the Partners Innovations team at http://www.partners.org/innovation
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| ID | Title | Description |
|---|---|---|
| FG000 | GYN Cancer Cases |
|
| FG001 | GYN Benign Controls |
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Study closed due to PI departure.
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| ID | Title | Description |
|---|---|---|
| BG000 | GYN Cancer Cases |
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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)] | No analysis was conducted because the PI left the institution. This lead to closure of the study. | Posted | Day 1 |
|
No time frame.
PI left the country, resulting in study closure. Adverse events were not assessed in this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GYN Cancer Cases |
|
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The study was closed when the Principal Investigator left the country to begin work in Finland. One subject was scanned, but never analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clare Tempany | DFCI | 617-732-7858 | ctempany@bwh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 19, 2020 | Sep 9, 2020 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 2, 2017 | Sep 22, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| ID | Term |
|---|---|
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005831 | Genital Diseases, Female |
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| 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. |
|
| Day 1 |
| QTI Total Mean Kurtosis | Total mean kurtosis evaluated by established methods using QTI | 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 | Day 1 |
| QTI Isotropic Heterogeneity MK1 | Isotropic heterogeneity MK1 value evaluated by established methods using QTI | Day 1 |
| QTI Fractional Anisotropy FA | Fractional anisotropy FA value evaluated by established methods using QTI | Day 1 |
| QTI Microscopic Fractional Anisotropy µFA | Microscopic fractional anisotropy µFA value evaluated by established methods using QTI | Day 1 |
| Median Overall Survival | Time from enrollment to death or last follow-up (censored) estimated using Kaplan-Meier methods | Up to 4 years |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| BG001 | GYN Benign Controls |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | GYN Benign Controls |
|
|
| Secondary | MRF T1 Relaxation Value | T1 relaxation values (unit: milliseconds) will be extracted from regions-of-interest based on anatomical structures using MRF. | PI left the country, resulting in study closure. | Posted | Day 1 |
|
|
| Secondary | MRF T2 Relaxation Value | T2 relaxation values (unit: milliseconds) will be extracted from regions-of-interest based on anatomical structures in using MRF. | PI left the country, resulting in study closure. | Posted | Day 1 |
|
|
| Secondary | QTI Total Mean Kurtosis | Total mean kurtosis evaluated by established methods using QTI | PI left the country, resulting in study closure. | Posted | Day 1 |
|
|
| 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 | PI left the country, resulting in study closure. | Posted | Day 1 |
|
|
| Secondary | QTI Isotropic Heterogeneity MK1 | Isotropic heterogeneity MK1 value evaluated by established methods using QTI | PI left the country, resulting in study closure. | Posted | Day 1 |
|
|
| Secondary | QTI Fractional Anisotropy FA | Fractional anisotropy FA value evaluated by established methods using QTI | PI left the country, resulting in study closure. | Posted | Day 1 |
|
|
| Secondary | QTI Microscopic Fractional Anisotropy µFA | Microscopic fractional anisotropy µFA value evaluated by established methods using QTI | PI left the country, resulting in study closure. | Posted | Day 1 |
|
|
| Secondary | Median Overall Survival | Time from enrollment to death or last follow-up (censored) estimated using Kaplan-Meier methods | PI left the country, resulting in study closure. | Posted | Up to 4 years |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | GYN Benign Controls |
| 0 | 0 | 0 | 0 | 0 | 0 |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |