Clinical trial NCT01752231: Optimization of Novel DCE-MRI Imaging Sequences for Cancer Therapy Monitoring
Official title: Optimization of Novel DCE-MRI Imaging Sequences for Cancer Therapy Monitoring
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Normal Volunteers
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
First posted: 2012-12-19
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Normal volunteers

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

Detailed description: PRIMARY OBJECTIVES:

I. Optimize and develop functional DCE-MRI pulse sequences, which involve the injection of MRI-visible contrast agents, for imaging in the head/neck, abdominal and pelvic regions.

II. Determine the ideal radiofrequency (RF) coil setup to maximize signal to noise ratio of the optimized pulse sequences.

III. Distill the findings of specific aims 1 and 2 into streamlined protocols that can be used in subsequent studies for cancer phenotyping and treatment monitoring in a quantitative manner.

IV. To establish a virtual reference image repository for future studies.

OUTLINE: 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: Inclusion Criteria:

All subjects are eligible except for the following special cases:

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Dynamic contrast-enhanced MRI (DCE-MRI) as a measure of tumor treatment response.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Jinha Park, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: