Human Papillomavirus-Related CarcinomaPhase 1NCT03634267
MRI-Guided Brachytherapy in Treating Participants With HPV-Associated Stage IB2-IVA Cervical or Stage II-IVA Vaginal Cancer
A Phase 1 study testing Internal Radiation Therapy and Magnetic Resonance Imaging in people with Human Papillomavirus-Related Carcinoma and Human Papillomavirus-Related Cervical Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This trial studies how well magnetic resonance imaging (MRI)-guided internal radiation therapy (brachytherapy) works in treating participants with human papillomavirus (HPV) associated stage IB2-IV cervical or stage II-IVA vaginal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Human Papillomavirus-Related Carcinoma, Human Papillomavirus-Related Cervical Carcinoma, Stage IB2 Cervical Cancer AJCC v8
- What is being tested?
- Internal Radiation Therapy and Magnetic Resonance Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2018to 26 Aug 2026
- Phase
- Phase 1
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with stage 1B2-IVA cervical cancer recommended to receive definitive chemoradiation including brachytherapy; or
- Women with stage II-IVA vaginal cancer recommended to receive definitive chemoradiation including brachytherapy.
Who cannot join
- Patient or tumor anatomy that requires use of a non-MRI-compatible applicator.
- Patients with implantable cardioverter-defibrillator, pacemaker or other implanted device or medical condition which precludes MRI acquisition.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MRI Guided Brachytherapy for HPV-Associated Cervical and Vaginal Malignancies
This trial studies how well magnetic resonance imaging (MRI)-guided internal radiation therapy (brachytherapy) works in treating participants with human papillomavirus (HPV) associated stage IB2-IV cervical or stage II-IVA vaginal cancer. Using MRI guidance during brachytherapy applicator placement may improve treatment planning in participants with cervical or vaginal cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine whether MRI guidance during internal radiation therapy applicator placement improves the high-risk clinical target volume (HR-CTV) D90 (dose to 90% of the high-risk clinical target volume) rate compared to conventional guidance, with ultrasound and freehand technique, for patients with cervical and vaginal cancer.
SECONDARY OBJECTIVES:
- Identify diffusion weighted MRI image features that can be used to identify sites of viable tumor following external beam radiotherapy as assessed by tumor aspirate cytology.
II. Determine if diffusion weighted MRI findings are associated with immune infiltration as assessed by multi-spectral flow cytometry.
III. Identify potential correlates between clinical outcomes (survival, progression) and these data objectives (brachytherapy dosimetry/therapeutic ratio, diffusion-weighted MRI imaging features, tumor aspirate cytology findings).
IV. Define the financial costs and feasibility of an MRI-guided brachytherapy approach to determine the overall healthcare quality value (outcomes/cost) of this novel approach for application at other brachytherapy centers.
OUTLINE:
Participants undergo MRI scan during internal radiation therapy applicator placement.
- Conditions
- Human Papillomavirus-Related Carcinoma, Human Papillomavirus-Related Cervical Carcinoma, Stage IB2 Cervical Cancer AJCC v8, Stage II Cervical Cancer AJCC v8, Stage II Vaginal Cancer AJCC v8, Stage IIA Cervical Cancer AJCC v8
- Being tested
- Internal Radiation Therapy, Magnetic Resonance Imaging
- Medical subject headings
- Uterine Cervical Neoplasms, Vaginal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internal Radiation TherapyRadiation
Also called BRACHYTHERAPY, internal radiation, Internal Radiation Brachytherapy, Radiation Brachytherapy
Undergo brachytherapy
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI Scan
Undergo MRI scan
| Study group | Role | What they receive |
|---|---|---|
| Treatment (MRI, internal radiation therapy) | Experimental | Participants undergo MRI scan during internal radiation therapy applicator placement. Receives: Radiation: Internal Radiation Therapy; Procedure: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of patients achieving high-risk clinical target volume (HR-CTV) dose to 90% (D90)
Rate will be compared to conventional guidance, with ultrasound and freehand technique. We will compare the HR-CTV D90 and other secondary dosimetry parameters (e.g. D2 cc bladder, D2 cc rectum etc.) between the initial scan (subsequent to ultrasound [US] guided or freehand applicator placement) and optimized (with magnetic resonance imaging [MRI] guided placement) treatment plan for each patient using McNemar's test.
Measured: Up to 4 years
Secondary outcomes (7)
Diffusion weighted imaging (DWI) outcomes
Measured: Up to 4 years
Biomarker measurements (tumor viability and tumor T cell profile) from tumor samples
A paired t-test will be used to compare apparent diffusion coefficient (ADC) areas for each biomarker.
Measured: Up to 4 years
Disease recurrence (local, regional, and distant)
determined via axial imaging (MRI or PET/CT) on interval follow-up
Measured: Up to 4 years
Overall survival
Measured: Up to 4 years
Progression-free survival
Measured: Up to 4 years
Incidence and severity of treatment-related toxicities
as defined via CTCAE v4.0
Measured: Up to 4 years
Cost difference associated with the MRI-guided versus the standard process
Billing and financial data will be calculated and compared to that of the conventional non-MRI-guided brachytherapy approach.
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 posted16 Aug 2018
- Study start3 Aug 2018
- Primary completion26 Aug 2026
- Study completion26 Aug 2026
Why it stopped: PI Request
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus-Related CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ann H Klopp, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03634267
- Sponsor's protocol ID
- 2017-0823
- Other IDs
- NCI-2018-01569, 2017-0823, P30CA016672
- Status last verified
- Sep 2026
- First submitted
- 3 Aug 2018
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Guided Brachytherapy for HPV-Associated Cervical and Vaginal Malignancies
- ClinicalTrials.gov ID
- NCT03634267
- Acronym / sponsor ID
- 2017-0823
- Conditions
- Human Papillomavirus-Related Carcinoma, Human Papillomavirus-Related Cervical Carcinoma, Stage IB2 Cervical Cancer AJCC v8, Stage II Cervical Cancer AJCC v8, Stage II Vaginal Cancer AJCC v8, Stage IIA Cervical Cancer AJCC v8
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI Request
- Enrolment
- 26 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 3 Aug 2018 (actual)
- Primary completion
- 26 Aug 2026 (actual)
- Study completion
- 26 Aug 2026 (actual)
- First posted
- 16 Aug 2018 (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.
This trial studies how well magnetic resonance imaging (MRI)-guided internal radiation therapy (brachytherapy) works in treating participants with human papillomavirus (HPV) associated stage IB2-IV cervical or stage II-IVA vaginal cancer. Using MRI guidance during brachytherapy applicator placement may improve treatment planning in participants with cervical or vaginal cancer.
Detailed description
PRIMARY OBJECTIVES:
- Determine whether MRI guidance during internal radiation therapy applicator placement improves the high-risk clinical target volume (HR-CTV) D90 (dose to 90% of the high-risk clinical target volume) rate compared to conventional guidance, with ultrasound and freehand technique, for patients with cervical and vaginal cancer.
SECONDARY OBJECTIVES:
- Identify diffusion weighted MRI image features that can be used to identify sites of viable tumor following external beam radiotherapy as assessed by tumor aspirate cytology.
II. Determine if diffusion weighted MRI findings are associated with immune infiltration as assessed by multi-spectral flow cytometry.
III. Identify potential correlates between clinical outcomes (survival, progression) and these data objectives (brachytherapy dosimetry/therapeutic ratio, diffusion-weighted MRI imaging features, tumor aspirate cytology findings).
IV. Define the financial costs and feasibility of an MRI-guided brachytherapy approach to determine the overall healthcare quality value (outcomes/cost) of this novel approach for application at other brachytherapy centers.
OUTLINE:
Participants undergo MRI scan during internal radiation therapy applicator placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (MRI, internal radiation therapy) | Experimental | Radiation: Internal Radiation Therapy, Procedure: Magnetic Resonance ImagingParticipants undergo MRI scan during internal radiation therapy applicator placement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women with stage 1B2-IVA cervical cancer recommended to receive definitive chemoradiation including brachytherapy; or
- Women with stage II-IVA vaginal cancer recommended to receive definitive chemoradiation including brachytherapy.
Key exclusion criteria (2 listed)
- Patient or tumor anatomy that requires use of a non-MRI-compatible applicator.
- Patients with implantable cardioverter-defibrillator, pacemaker or other implanted device or medical condition which precludes MRI acquisition.
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 |
|---|---|---|
| Internal Radiation TherapyAlso: BRACHYTHERAPY, internal radiation, Internal Radiation Brachytherapy, Radiation BrachytherapyUndergo brachytherapy | Radiation | Treatment (MRI, internal radiation therapy) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI ScanUndergo MRI scan | Procedure or surgery | Treatment (MRI, internal radiation therapy) |
Primary outcome
Percent of patients achieving high-risk clinical target volume (HR-CTV) dose to 90% (D90)
Time frame: Up to 4 years
Rate will be compared to conventional guidance, with ultrasound and freehand technique. We will compare the HR-CTV D90 and other secondary dosimetry parameters (e.g. D2 cc bladder, D2 cc rectum etc.) between the initial scan (subsequent to ultrasound [US] guided or freehand applicator placement) and optimized (with magnetic resonance imaging [MRI] guided placement) treatment plan for each patient using McNemar's test.
7 secondary outcomes
Diffusion weighted imaging (DWI) outcomes
Time frame: Up to 4 years
Biomarker measurements (tumor viability and tumor T cell profile) from tumor samples
Time frame: Up to 4 years
Disease recurrence (local, regional, and distant)
Time frame: Up to 4 years
Overall survival
Time frame: Up to 4 years
Progression-free survival
Time frame: Up to 4 years
Incidence and severity of treatment-related toxicities
Time frame: Up to 4 years
Cost difference associated with the MRI-guided versus the standard process
Time frame: Up to 4 years
Results and safety
The study was stopped early (reason given: PI Request). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Ann H Klopp principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Internal Radiation Therapy and Magnetic Resonance Imaging in people with Human Papillomavirus-Related Carcinoma and Human Papillomavirus-Related Cervical Carcinoma, run by M.D. Anderson Cancer Center at 1 site 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 2 inclusion and 2 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 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: PI Request). Results are not available in the source record.
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?
Percent of patients achieving high-risk clinical target volume (HR-CTV) dose to 90% (D90) (time frame: Up to 4 years). 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 15 Sep 2026.