NCT02340715

Brief Summary

The purpose of this study is to determine if it would be helpful to use advanced MRI imaging techniques to take additional views of the tumor target for radiation treatment planning or treatment follow-up MRI.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
158

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2009

Longer than P75 for all trials

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

February 1, 2009

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 19, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

October 31, 2017

Completed
Last Updated

October 31, 2017

Status Verified

October 1, 2017

Enrollment Period

6.3 years

First QC Date

September 10, 2014

Results QC Date

May 22, 2017

Last Update Submit

October 30, 2017

Conditions

Keywords

Anal canalBrainBreastCervixEsophagusGynecologyHead and NeckLungPancreasPrimary liver or liver metastasesProstate cancerSarcoma

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Successfully Contributing MRI Data

    We tested these Advanced MR protocols to evaluate which ones would best visualize the target region. This helped us determine the optimum MR SIM protocols for different sites that became clinical standard.

    up to 4 weeks from imaging

Study Arms (1)

MRI for treatment planning or follow up

MRI for treatment planning for radiation therapy or those who have completed treatment and are receiving follow up care.

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects who are planning to have radiation therapy for their cancer.

You may qualify if:

  • Patients aged 18 years older of any race or gender with anal canal, brain, breast, cervix, esophagus, gynecology, head and neck, lung, pancreas, primary liver or liver metastases, prostate cancer or sarcoma either undergoing MRI scan for radiation treatment planning or a post treatment MRI
  • Voluntarily signs an IRB approved consent form

You may not qualify if:

  • Inability to obtain informed consent from the patient or their medical power of attorney
  • Patients who are not undergoing MR for radiation treatment planning
  • Patients who will not have MRI scans after treatment
  • Patients with pacemakers or other non-MRI compatible metallic implants
  • Pregnant women, by self report using a standard MRI questionnaire
  • Patients who will not receive contrast agent as part of their standard MR, will participate only in the non-contrast portion of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

  • Khoo VS, Dearnaley DP, Finnigan DJ, Padhani A, Tanner SF, Leach MO. Magnetic resonance imaging (MRI): considerations and applications in radiotherapy treatment planning. Radiother Oncol. 1997 Jan;42(1):1-15. doi: 10.1016/s0167-8140(96)01866-x.

    PMID: 9132820BACKGROUND

MeSH Terms

Conditions

NeoplasmsProstatic NeoplasmsSarcoma

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesNeoplasms, Connective and Soft TissueNeoplasms by Histologic Type

Results Point of Contact

Title
Ergun Ahunbay
Organization
Medical College of Wisconsin

Study Officials

  • Ergun Ahunbay, PhD

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Physics

Study Record Dates

First Submitted

September 10, 2014

First Posted

January 19, 2015

Study Start

February 1, 2009

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

October 31, 2017

Results First Posted

October 31, 2017

Record last verified: 2017-10

Locations