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

City of Hope

Status: Terminated

Conditions: Normal Volunteers

Study type: Observational

Funder types: Other

Identifiers

NCT01752231

12050

NCI-2012-03002 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

1 participants in 1 patient group

DCE-MRI (dynamic contrast-enhanced MRI)

Description:

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.