Dual-Time Point (DTP) FDG PET CT for the Post-Treatment Assessment of Head and Neck Tumors Following Definitive Chemoradiation Therapy

• Status: Recruiting
• Trial end date: 2019-12-01
• Target enrollment: 50
• Participant gender: All

Summary

The goal of this clinical research study is to compare the results of a dual time point (standard and delayed) FDG PET/CT of the head and neck before and after chemo-radiation therapy.

This is an investigational study. The FDG PET/CT is delivered using FDA approved and commercially available methods. It is considered investigational to use delayed PET/CT scans to study the effects of chemo-radiation treatment.

The FDG injections and PET/CT scans (about 1 hour after FDG injection) will be done as part of your standard of care.

The delayed (about 3 hours after FDG injection) PET/CT scans will be provided at no cost to you.

Up to 50 participants will be enrolled in this study. All will take part at MD Anderson.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center

Criteria

Inclusion Criteria:

1) Adult (>18 years of age) with pathology proven cervical nodal metastasis from a head and neck primary squamous cell carcinoma with planned treatment with definitive chemoradiation.

Exclusion Criteria:

1. Children.

2. No evidence of cervical nodal metastasis.

3. Active infection of the head and neck.

4. Known allergy to FDG, iodine or gadolinium-based contrast agents.

5. Blood glucose (>200 mg/dl).

6. Severe renal dysfunction [glomerular filtrate rate (within 30 days) less than 30].

7. Pregnant women