Functional Imaging of Tumor and Normal Tissue

NCT ID: NCT00933114

Last Updated: 2012-04-11

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 21 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2011-09-30

Brief Summary

Dynamic contrast-enhanced (DCE) - magnetic resonance imaging (MRI), diffusion-weighted (DW)-MRI, and fludeoxyglucose - positron emission tomography - computed tomography (FDG-PET-CT) are three modalities that generate non-invasive, functional images of tumors and normal tissues based on physiologic properties including perfusion, vascular permeability and glucose metabolism. Demonstrating that these parameters are associated with clinical outcome, either efficacy or toxicity, could enhance the ability to select patients for different treatment strategies and improve the therapeutic ratio.

Detailed Description

Patients will undergo functional imaging studies, DCE-MRI pre-treatment (twice) and after 1 week of Radiation Therapy (RT) and PET scans - pre-treatment and after 1 week of RT. Parotid gland saliva production will also be measured at baseline and at 3, 6, and 12 months of follow-up.

Conditions

Head and Neck Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Functional Imaging

Functional imaging with MRI and PET

MRI and PET imaging

Intervention Type: PROCEDURE

Dynamic Enhanced Magnetic Resonance Imaging (DEC-MRI) and positron emission tomography (PET) scan at baseline and after 1 week of radiation therapy

Interventions

MRI and PET imaging

Dynamic Enhanced Magnetic Resonance Imaging (DEC-MRI) and positron emission tomography (PET) scan at baseline and after 1 week of radiation therapy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Histologically documented squamous cell carcinoma of the head and neck (AJCC stages II-IV, M0)
• Eligible anatomic sites: Oral cavity, oropharynx, hypopharynx, supraglottic and glottic larynx, or nasopharynx
• Curative intent concurrent chemoradiation
• Age > 18 years
• Karnofsky Performance Status > 60
• Able to undergo MRI with contrast (gadolinium) and/or FDG PET scan

Exclusion Criteria

• Diabetes other than diet controlled
• MRI Absolute Contraindications including:

• Glomerular filtration rate < 60 ml/min
• Weight < 350 lb or current device limitations
• Metallic foreign bodies in the eye
• Cardiac pacemakers
• Clips in the central nervous system (ferromagnetic haemostatic)
• Automatic internal cardiac defibrillators
• Cochlear implants
• Shrapnel in vital locations
• Pregnant (positive pregnancy test) or lactating

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David S Yoo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University Medical Center, Dept Radiation Oncology

David M Brizel, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University Medical Center Dept Radiation Oncology

Locations

Duke University Medical Center, Department of Radiation Oncology

Durham, North Carolina, United States

Countries

United States

References

Brizel DM, Rosner GL, Prosnitz LR, Dewhirst MW. Patterns and variability of tumor oxygenation in human soft tissue sarcomas, cervical carcinomas, and lymph node metastases. Int J Radiat Oncol Biol Phys. 1995 Jul 15;32(4):1121-5. doi: 10.1016/0360-3016(95)00106-9.

Reference Type: BACKGROUND

PMID: 7607933 (View on PubMed)

Kirkpatrick JP, Cardenas-Navia LI, Dewhirst MW. Predicting the effect of temporal variations in PO2 on tumor radiosensitivity. Int J Radiat Oncol Biol Phys. 2004 Jul 1;59(3):822-33. doi: 10.1016/j.ijrobp.2004.02.015.

Reference Type: BACKGROUND

PMID: 15183486 (View on PubMed)

Other Identifiers

Pro00014784

Identifier Type: -

Identifier Source: org_study_id