FDG-PET/CT as a Predictive Marker of Tumor Response and Patient Outcome:
Prospective Validation in Non-small Cell Lung Cancer

Protocol Documents

Protocol-ACRIN 6678 Amendment 4, 11.16.09 [PDF]

SOC-ACRIN 6678 Amendments 3 & 4, 11.19.09 [PDF]

Informed Consent-ACRIN 6678 [DOC]

Principal Investigator: Wolfgang Weber, MD

Status: Open

Main Objectives:

• To test whether a metabolic response, defined as a ≥ 25% decrease in peak tumor SUV post-cycle 1 of chemotherapy, provides early prediction of treatment outcome (tumor response and patient survival).
• To determine the test-retest reproducibility of quantitative assessment of tumor FDG uptake by SUVs.
• To evaluate in an exploratory analysis the time course of treatment induced changes in tumor FDG uptake.
• To evaluate in an exploratory analysis changes in tumor volume during chemotherapy by multislice CT.

Participants:  Eligible participants for this trial are patients with advanced NSCLC (for Groups A and B: Stage IIIB with pleural effusion or Stage IV, who are scheduled to undergo palliative chemotherapy; for Group C, Stages IIIA, IIIB, or IV, with unspecified therapy) who meet the eligibility criteria. Patients with previously treated NSCLC may participate so long as they meet the eligibility criteria.