Positron Emission Tomography/Magnetic Resonance Imaging in Patients

NCT01557881 | Terminated Results DMC

• 2 other identifiers: CASE15Z11NCI-2012-00169
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial studies positron emission tomography (PET)/magnetic resonance imaging (MRI) in patients undergoing PET/computed tomography (CT). Diagnostic procedures, such as PET/MRI, may help doctors diagnose cancer or help doctors predict a patient's response to treatment

Conditions

Colon Cancer; Head and Neck Cancer; Lung Cancer; Lymphoma; Malignant Neoplasm; Melanoma; Unspecified Adult Solid Tumor, Protocol Specific; Unspecified Childhood Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (3)

• Standardized Uptake Value (SUV) on PET/CT Compared to PET/MRI

  SUVs for various normal tissues such as liver, cardiac blood pool, and bone will be used. Selected lesions will be assessed as well. Maximum and mean SUVs will be measured for each imaging device. The SUVs and tumor/background ratios will be measured.

  After PET/MRI

• Individual Quality Scores, Comprised of Various Qualities of the Image and Include Contrast, Brightness, Resolution, Etc.

  A Likert five point scale will be used. Quality scores will be compared using a Wilcoxon signed rank test.

  After PET/MRI

• Comparison of Quality Scores (PET/CT vs PET/MRI), Comprised of Various Qualities of the Image and Include Contrast, Brightness, Resolution, Etc.

  A Likert five point scale will be used. Quality scores will be compared using a Wilcoxon signed rank test.

  After PET/MRI

Study Arms (1)

Diagnostic (PET/MRI)

EXPERIMENTAL

After undergoing standard PET/CT, patients undergo PET/MRI.

Device: magnetic resonance imaging with positron emission tomography scanning

Interventions

magnetic resonance imaging with positron emission tomography scanning DEVICE

University Hospitals Seidman Cancer Center \[SCC\] will house the Philips Ingenuity TF PET/MR, which is a hybrid scanner that merges magnetic resonance imaging with positron emission tomography scanning. University Hospitals is one of only five hospitals in the world with this technology. The PET/MRI system consists of two imaging scanners used sequentially as in PET/CT. The 3Tesla MRI component provides the high resolution that is necessary for soft tissue contrast and functional information on perfusion, diffusion, or metabolism. PET provides information about cellular metabolism and receptor status.

Also known as: FDG-PET, PET, PET scan, tomography, emission computed, MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging, Philips Ingenuity TF PET/MR

Diagnostic (PET/MRI)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Only patients who are referred by their physician to have a clinical PET/CT will be eligible to participate in the study
• we propose to obtain a second PET/MRI on 100 patients after their clinical PET/CT imaging that spans several disease categories and includes the following cancers: lung, colon, melanoma, head/neck and lymphoma
• In addition to oncology patients, we anticipate imaging a subset of non-cancer patients who will also be imaged subsequent to their clinical PET/CT who will be referrals from neurology and cardiology
• All subjects will be at least 18 years old, or if under 18, parents or guardians must give consent
• Subjects must be stable and have experienced no adverse events from previous clinical PET/CT examination

You may not qualify if:

• Subjects unwilling or unable to sign the informed consent form
• Subjects who are cognitively impaired and thus unable to give informed consent
• Patients who are pregnant

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms; Head and Neck Neoplasms; Lung Neoplasms; Lymphoma; Neoplasms; Melanoma

Interventions

Magnetic Resonance Imaging; Positron-Emission Tomography; Tomography, Emission-Computed

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Interpretation, Computer-Assisted; Image Enhancement; Photography; Radionuclide Imaging; Diagnostic Techniques, Radioisotope

Limitations and Caveats

Outcome data not collected.

Results Point of Contact

• Title: Philipp Frank Graner
• Organization: Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

philipp.graner@uhhospitals.org

+1 216-844-8275

Study Officials

• Peter Faulhaber

  University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

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: March 16, 2012
• First Posted: March 20, 2012
• Study Start: February 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: February 24, 2020
• Results First Posted: February 24, 2020

Record last verified: 2020-02

Locations

US (1)