Optimization of Novel DCE-MRI Imaging Sequences for Cancer Therapy Monitoring

NCT01752231 | Terminated DMC

• 2 other identifiers: 12050NCI-2012-03002
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot clinical trial studies dynamic contrast enhanced (DCE)-magnetic resonance imaging (MRI) in diagnosing cancer. New diagnostic procedures, such as DCE-MRI may help find and diagnose cancer

Conditions

Normal Volunteers

Outcome Measures

Primary Outcomes (1)

• Dynamic contrast-enhanced MRI (DCE-MRI) as a measure of tumor treatment response.

  Analysis of DCE-MRI data will be by semi-quantitative metrics such as the area under the curve (AUC), the slopes of contrast agent uptake and washout curves as well as peak contrast agent uptake. Alternatively quantitative metrics based upon pharmacokinetic modeling will be derived. The model is the 2-compartment Kety model from which volume transfer constants between compartments and volume of the tissue compartments can be calculated.

  1 year

Study Arms (1)

DCE-MRI (dynamic contrast-enhanced MRI)

Patients undergo DCE-MRI over approximately 30-60 minutes consisting of an anatomical scout image to localize the region of interest, a set of pre-injection scans to calibrate the dynamic image set, a dynamic image set during which contrast agent will be injected, and a set of post-injection scans to calibrate the DCE-MRI database.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Normal volunteers

You may qualify if:

• All subjects are eligible except for the following special cases:

You may not qualify if:

• Female subjects who are or may be pregnant will NOT be eligible.
• The minimum age for all subjects is 18 years old. No subjects under the age of 18 shall be considered.
• If subject has received an imaging contrast agent of any kind within the past 7 days, they shall not be included in the study.
• Subjects for whom MRI is contraindicated as set forth by the City of Hope Department of Radiology. These include:
• electrical implants such as cardiac pacemakers or perfusion pumps
• ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants
• ferromagnetic objects such as jewelry or metal clips in clothing
• pre-existing medical conditions, including a likelihood of developing seizures or anxiety disorders such as claustrophobia, panic attacks or any psychiatric disorder
• any greater than normal potential for cardiac arrest
• any subject with known kidney insufficiency function as evidenced by an abnormal serum creatinine (normal = 0.6 - 1.5 mg/dL) from a blood test performed on the subject within the past 6 months of the study date.
• Any subject with abnormal creatinine clearance (normal = 100-130 ml/min/1.73m2), as measured by a direct test or from plasma creatinine (14) levels shall be excluded.
• Normal subjects with a history of severe claustrophobia will not be eligible.
• For ease of recruiting and study management purposes, only subjects who can give consent in English shall be eligible for this study.

Sponsors & Collaborators

• City of Hope Medical Center: lead

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

Study Officials

• Jinha Park, MD, Ph.D.

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2012
• First Posted: December 19, 2012
• Study Start: July 23, 2013
• Primary Completion: August 29, 2017
• Study Completion: August 29, 2017
• Last Updated: December 21, 2017

Record last verified: 2017-12

Locations

US (1)