NCT01991808

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 11, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2016

Completed
3 years until next milestone

Results Posted

Study results publicly available

November 26, 2019

Completed
Last Updated

November 26, 2019

Status Verified

November 1, 2019

Enrollment Period

3.2 years

First QC Date

November 11, 2013

Results QC Date

October 21, 2019

Last Update Submit

November 25, 2019

Conditions

Carcinoma of the Cervix, Carcinoma or Carcinosarcoma of the Uterus

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Adverse Events

    2 years

Study Arms (1)

DCE-MRI

EXPERIMENTAL
Radiation: Radiotherapy

Interventions

RadiotherapyRADIATION
DCE-MRI

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Uterine Cervical NeoplasmsCarcinoma

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

Title
Lilie Lin, MD
Organization
University of Pennsylvania
lin@uphs.upenn.edu
215-622-6515

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2013

First Posted

November 25, 2013

Study Start

October 1, 2013

Primary Completion

December 8, 2016

Study Completion

December 8, 2016

Last Updated

November 26, 2019

Results First Posted

November 26, 2019

Record last verified: 2019-11

Locations

US(1)