TheranosticTrials.org

Clinical Trial · NCT00765986

Pilot Study of 18F-FAZA in Assessing Early Functional Response in Patients With Inoperable Non Small Cell Lung Cancer Undergoing Radiotherapy or Chemo-radiotherapy

Overview

Non-small cell lung cancer (NSCLC) has a poor prognosis if not caught early enough. One of the factors that may impact the ability to control NSCLC is low oxygen levels (hypoxia) inside the tumour. This study will use 18F-FAZA PET scans to assess whether patients have hypoxic tumours and to monitor the changes to the hypoxic areas of a tumour during currently available standard treatment. It is hypothesized that 18F-FAZA PET may predict response to treatment, local control, and/or survival in NSCLC.

Sponsor

AHS Cancer Control Alberta

Contacts

Lai Schrader (CONTACT)

lai.schrader@albertahealthservices.ca

780.432.8464

Dr. Wilson Roa, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT00765986

Drug / Compound

FAZA

Isotope(s):
Target(s):
  • Hypoxia
Ligand Class: Small Molecules

FDG

Isotope(s):
Target(s):
  • Glucose Transport
Ligand Class: Small Molecules

Eligibility

Inclusion

  • Patients with American Joint Committee on Cancer (AJCC) Stage I, II, IIIA, or IIIB with detectable tumour that can be encompassed by radiation therapy fields, including both primary tumour and the involved regional lymph nodes.
  • Patients must have at least one measurable lesion ≥ 1 cm on CT
  • The prescribed radiotherapy dose must be a minimum of 60 Gy in 30 fractions
  • Able and willing to follow instructions and comply with the protocol
  • Patients with histologically-proven, by biopsy or cytology, unresected lung cancer of the following histological types: squamous cell carcinoma; adenocarcinoma; undifferentiated large cell carcinoma, and non-small cell, not otherwise specified (NOS, diagnosis on cytology alone)
  • Patients must be deemed to be suitable to undergo definitive (i.e. potentially curable) chemoradiotherapy or radiotherapy by the treating Physician.
  • ECOG/Zubrod status 0-1

Exclusion

  • Patients who have undergone complete or subtotal tumour resection
  • Nursing or pregnant females
  • No distant or metastasis, prior chemotherapy, or thoracic neck or radiotherapy
  • Patients with post-resection intrathoracic tumour recurrence
  • Patients eligible for definitive surgery (patients who are eligible for surgery, but surgery did not proceed are eligible for this trial)
  • Inability to lay in supine position for approximately one hour
  • Evidence of any small cell histology