MRI in Finding Hypoxia in Patients Undergoing Chemo and Radiation for Head and Neck Cancer

NCT00896350 | Terminated Phase 1 DMC

• 3 other identifiers: SCCC-02308CDR0000637640NCI-2011-02811
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Diagnostic procedures, such as functional MRI, may help measure oxygen levels in tumor cells and may help in planning cancer treatment. PURPOSE: This phase I trial is studying functional MRI to see how well it works in finding hypoxia in patients undergoing chemotherapy and radiation therapy for stage III or stage IV head and neck cancer.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (2)

• MRI signal sensitivity to oxygen

  MRI signal sensitivity to oxygen breathing and delayed contrast-enhancement (DCE)

  12 weeks

• Tumor shrinkage and blood oxygen association

  Association between tumor shrinkage and blood oxygen level dependent

  12 weeks

Secondary Outcomes (1)

• Correlate tumor hypoxia with patient prognosis and treatment response

  12 weeks

Study Arms (1)

BOLD MRI

EXPERIMENTAL

Determine the amount of oxygen supply to tumors.

Drug: Standard Care Chemoradiation

Interventions

Standard Care Chemoradiation DRUG

External beam radiation to the neck and tumor site of head and neck. Concurrent platinum based chemotherapy. External beam "boost" at discretion of treating physician.

BOLD MRI

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed squamous cell carcinoma of the head and neck * Stage III or IV disease * Measurable disease * Scheduled to undergo standard treatment including radiation therapy and chemotherapy * Participation on study # 092004-010 for tissue procurement PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Serum creatinine ≤ 1.5 OR creatinine clearance ≥ 40 * Body mass index ≤ 34 Kg/m\^2 * Not claustrophobic * No other contraindications to MRI (i.e., implanted pacemaker device) * Not pregnant or nursing * Negative pregnancy test * No allergy to gadolinium PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Baran Sumer, MD

  Simmons Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2009
• First Posted: May 11, 2009
• Study Start: July 8, 2009
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: February 18, 2019

Record last verified: 2019-02

Locations

US (1)