Gynecologic CancerNCT04530019
Brachytherapy Innovations in Gynecologic Cancer
An observational study of Gynecologic Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
Trial summary
In this pilot study, the investigators will test tools designed to more precisely identify, define and create a radiation treatment plan to tumor remnants as separate from fibrotic or normal tissue in a Magnetic Resonance (MR) simulator in the department of radiation oncology. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Gynecologic Cancer
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Dec 2032
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with gynecological cancer, ages 18 and older.
Who may be able to join
- Participants must meet the following criteria on screening examination to be eligible to participate in the study:
- Participants must have histologically or cytologically confirmed carcinoma. Central pathology review is not required; however, pathology will be reviewed at the Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins.
- Any patient eligible for internal implantation without MR guidance will be considered eligible for this protocol. Standard criteria for internal implantation include:
- Carcinoma of the cervix: Stage I-IVA or vaginal recurrence Carcinoma of the uterus: Stage IIIB (vaginal involvement), inoperable, or vaginal recurrence Carcinoma of the vagina: Stage I-IVA or vaginal recurrence Carcinoma of the vulva: Stage I-IVA or recurrence Carcinoma of the urethra based on treating physician's discretion
- Patients who have received prior radiation or chemotherapy may be enrolled on this study.
- Age > 18 years. Children do not develop these malignancies and therefore are not considered candidates for this trial.
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- Life expectancy of greater than 6 months.
- Eastern Cooperative Oncology Group (ECOG) performance scale. ECOG status of <2, based on treating physician's discretion
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- 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.
- Absolute neutrophil count < 500 at the time of brachytherapy
- A history of metal in the head or eyes
About this study
Official title: Magnetic Resonance-Guided Brachytherapy Innovations in Gynecologic Cancer-Methods to Identify Remnant Tumor Versus Scar Tissue in Relation to Radiation Therapy
In this pilot study, the investigators will test tools designed to more precisely identify, define and create a radiation treatment plan to tumor remnants as separate from fibrotic or normal tissue in a Magnetic Resonance (MR) simulator in the department of radiation oncology. The investigators will examine if this beneficial for tumor versus normal tissue delineation, will result in more precise tumor targeting with radiation in an efficient manner and whether there would be fewer toxicities.
Read the detailed description
This study is a clinical research study following patients for toxicity after brachytherapy, and the investigators will be using the D2cc as a surrogate biomarker for determining risk for toxicity in addition to utilizing toxicity measured from physician-queries using the Common Toxicity Criteria for Adverse Events (CTCAE v. 4.0). Patients will have images analyzed for quantification of residual tumor versus fibrosis. The investigators will utilize Magnetic Resonance (MR) tracking, and pilot test: an endovaginal coil, a deflectable Magnetic Resonance stylet, real-time planning software, and auto-segmentation of normal tissues and tumor.
Standard T2-weighted MR images are generally recommended given the soft-tissue visualization without the need for contrast media injection. At the time of brachytherapy, acquisition of para-axial, para-sagittal and para-coronal images should be performed with the orientations being orthogonal (para-axial) and parallel (para-sagittal/para-coronal) to the intrauterine tandem. Slice thickness has a direct impact on applicator reconstruction accuracy, and a slice thickness of ≤3mm is required on the NRG Oncology study (NRG-GY006).
More advanced multi-parametric magnetic resonance imaging (mmpMRI) series show significant promise. A Dynamic Contrast Enhanced (DCE) study identified one voxel cluster consisting of low-enhancing voxels based on the relative signal increase (RSI) time series that was related to locoregional control (adjusted p-value 0.048). Diffusion-weighted (DW)-MRI is used to identify areas of dense residual tumor.31 In one analysis, the mean apparent diffusion coefficient (ADC) value of the primary tumor on pretreatment MRI was an independent predictor of disease-free survival in cervical cancer patients treated with chemoradiation. However, artifacts result in inconsistent contouring at the time of brachytherapy. 3D Slicer is a free open source software application for medical image computing, and will be utilized for some aspects of research in MR Simulator Suite.
- Conditions
- Gynecologic Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MR Group | Following standard MRI-guided Brachytherapy, patients will have images analyzed for quantification of residual tumor versus fibrosis. We will pilot-test an endovaginal coil, a deflectable MR stylet, real-time planning software, and auto-segmentation of normal and tumor tissue. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity rates calculated for patients enrolled on this study
Toxicity rates will be calculated using the Common Terminology Criteria for Adverse Events (CTCAE v. 4.0)
Measured: Up to 24 months post treatment
Secondary outcomes (1)
Change in tumor as assessed by MRI
Compare changes in tumor based on MRI.
Measured: Prior to treatment/at diagnosis and post-brachytherapy treatment up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study startOct 2024 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionDec 2032 (estimated)
Why it stopped: The study never opened.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Akila Viswanathan, MD, Study chair, Johns Hopkins, School of Medicine, Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04530019
- Sponsor's protocol ID
- IRB00244401
- Status last verified
- Nov 2024
- First submitted
- 24 Aug 2020
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance-Guided Brachytherapy Innovations in Gynecologic Cancer-Methods to Identify Remnant Tumor Versus Scar Tissue in Relation to Radiation Therapy
- ClinicalTrials.gov ID
- NCT04530019
- Acronym / sponsor ID
- IRB00244401
- Conditions
- Gynecologic Cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study never opened.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 28 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this pilot study, the investigators will test tools designed to more precisely identify, define and create a radiation treatment plan to tumor remnants as separate from fibrotic or normal tissue in a Magnetic Resonance (MR) simulator in the department of radiation oncology. The investigators will examine if this beneficial for tumor versus normal tissue delineation, will result in more precise tumor targeting with radiation in an efficient manner and whether there would be fewer toxicities.
Detailed description
This study is a clinical research study following patients for toxicity after brachytherapy, and the investigators will be using the D2cc as a surrogate biomarker for determining risk for toxicity in addition to utilizing toxicity measured from physician-queries using the Common Toxicity Criteria for Adverse Events (CTCAE v. 4.0). Patients will have images analyzed for quantification of residual tumor versus fibrosis. The investigators will utilize Magnetic Resonance (MR) tracking, and pilot test: an endovaginal coil, a deflectable Magnetic Resonance stylet, real-time planning software, and auto-segmentation of normal tissues and tumor.
Standard T2-weighted MR images are generally recommended given the soft-tissue visualization without the need for contrast media injection. At the time of brachytherapy, acquisition of para-axial, para-sagittal and para-coronal images should be performed with the orientations being orthogonal (para-axial) and parallel (para-sagittal/para-coronal) to the intrauterine tandem. Slice thickness has a direct impact on applicator reconstruction accuracy, and a slice thickness of ≤3mm is required on the NRG Oncology study (NRG-GY006).
More advanced multi-parametric magnetic resonance imaging (mmpMRI) series show significant promise. A Dynamic Contrast Enhanced (DCE) study identified one voxel cluster consisting of low-enhancing voxels based on the relative signal increase (RSI) time series that was related to locoregional control (adjusted p-value 0.048). Diffusion-weighted (DW)-MRI is used to identify areas of dense residual tumor.31 In one analysis, the mean apparent diffusion coefficient (ADC) value of the primary tumor on pretreatment MRI was an independent predictor of disease-free survival in cervical cancer patients treated with chemoradiation. However, artifacts result in inconsistent contouring at the time of brachytherapy. 3D Slicer is a free open source software application for medical image computing, and will be utilized for some aspects of research in MR Simulator Suite.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MR Group | – | –Following standard MRI-guided Brachytherapy, patients will have images analyzed for quantification of residual tumor versus fibrosis. We will pilot-test an endovaginal coil, a deflectable MR stylet, real-time planning software, and auto-segmentation of normal and tumor tissue. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with gynecological cancer, ages 18 and older.
Key inclusion criteria (9 listed)
- Participants must meet the following criteria on screening examination to be eligible to participate in the study:
- Participants must have histologically or cytologically confirmed carcinoma. Central pathology review is not required; however, pathology will be reviewed at the Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins.
- Any patient eligible for internal implantation without MR guidance will be considered eligible for this protocol. Standard criteria for internal implantation include:
- Carcinoma of the cervix: Stage I-IVA or vaginal recurrence Carcinoma of the uterus: Stage IIIB (vaginal involvement), inoperable, or vaginal recurrence Carcinoma of the vagina: Stage I-IVA or vaginal recurrence Carcinoma of the vulva: Stage I-IVA or recurrence Carcinoma of the urethra based on treating physician's discretion
- Patients who have received prior radiation or chemotherapy may be enrolled on this study.
Key exclusion criteria (3 listed)
- 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.
- Absolute neutrophil count < 500 at the time of brachytherapy
- A history of metal in the head or eyes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Toxicity rates calculated for patients enrolled on this study
Time frame: Up to 24 months post treatment
Toxicity rates will be calculated using the Common Terminology Criteria for Adverse Events (CTCAE v. 4.0)
1 secondary outcome
Change in tumor as assessed by MRI
Time frame: Prior to treatment/at diagnosis and post-brachytherapy treatment up to 14 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
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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.
Akila Viswanathan, MD study chair
Johns Hopkins, School of Medicine, Radiation Oncology
Questions about this trial
What is this clinical trial studying?
An observational study of Gynecologic Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
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 9 inclusion and 3 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: withdrawn, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Toxicity rates calculated for patients enrolled on this study (time frame: Up to 24 months post treatment). 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 29 Nov 2024.