Carcinoma of the Cervix, Carcinoma or Carcinosarcoma of the UterusNCT01991808
Suitability of DCE-MRI for Detection of Vascular Changes After VBT
A study testing Radiotherapy in people with Carcinoma of the Cervix, Carcinoma or Carcinosarcoma of the Uterus, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
This is a pilot study of DCE MR imaging to detect vascular changes in the vagina during and after radiotherapy n patients receiving adjuvant brachytherapyfor cervical or endometrial cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Carcinoma of the Cervix, Carcinoma or Carcinosarcoma of the Uterus
- What is being tested?
- Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to 8 Dec 2016
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be 18 years of age.
- Must have histologically confirmed carcinoma of the cervix, carcinoma or carcinosarcoma of the uterus.
- Subjects are receiving intracavitary brachytherapy.
- ECOG performance status of 0-2.
- Creatinine clearance 30.
Who cannot join
- Subjects with an inability to tolerate MR imaging (i.e. claustrphobia)
- Study subjects who have contraindication to MRI scanning such as but not limited to subjects with pacemakers, metal fragments in the eye or certain metallic implants.
- Patients who do not speak or read English.
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Pilot Study to Assess the Suitability of DCE-MRI for Detection of Vascular Changes After Vaginal Brachytherapy
This is a pilot study of DCE MR imaging to detect vascular changes in the vagina during and after radiotherapy n patients receiving adjuvant brachytherapyfor cervical or endometrial cancer.
- Being tested
- Radiotherapy
- Medical subject headings
- Uterine Cervical Neoplasms, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| DCE-MRI | Experimental | Not described Receives: Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startOct 2013
- Primary completion8 Dec 2016
- Study completion8 Dec 2016
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 Carcinoma of the Cervix, Carcinoma or Carcinosarcoma of the UterusStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01991808
- Sponsor's protocol ID
- UPCC 26812
- Status last verified
- Nov 2019
- First submitted
- 11 Nov 2013
- Last updated
- 26 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess the Suitability of DCE-MRI for Detection of Vascular Changes After Vaginal Brachytherapy
- ClinicalTrials.gov ID
- NCT01991808
- Acronym / sponsor ID
- UPCC 26812
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- 8 Dec 2016 (actual)
- Study completion
- 8 Dec 2016 (actual)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Posted 26 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study of DCE MR imaging to detect vascular changes in the vagina during and after radiotherapy n patients receiving adjuvant brachytherapyfor cervical or endometrial cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DCE-MRI | Experimental | Radiation: Radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must be 18 years of age.
- Must have histologically confirmed carcinoma of the cervix, carcinoma or carcinosarcoma of the uterus.
- Subjects are receiving intracavitary brachytherapy.
- ECOG performance status of 0-2.
- Creatinine clearance 30.
Key exclusion criteria (3 listed)
- Subjects with an inability to tolerate MR imaging (i.e. claustrphobia)
- Study subjects who have contraindication to MRI scanning such as but not limited to subjects with pacemakers, metal fragments in the eye or certain metallic implants.
- Patients who do not speak or read English.
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 |
|---|---|---|
| Radiotherapy | Radiation | DCE-MRI |
Primary outcome
Number of Participants With Adverse Events
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiotherapy in people with Carcinoma of the Cervix, Carcinoma or Carcinosarcoma of the Uterus, run by Abramson Cancer Center at Penn Medicine 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 5 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: finished, as of the sponsor's last update on 26 Nov 2019. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Nov 2019). 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 Participants With Adverse Events (time frame: 2 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 26 Nov 2019.