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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by AHS Cancer Control Alberta
Sponsor:
Information provided by (Responsible Party):
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT00765986
First received: October 2, 2008
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Lung Neoplasm
Cell Hypoxia
Other: 18F-FAZA
Other: 18F-Fluorodeoxyglucose (18F-FDG)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Study to See if a New Type of Imaging Can Help Our Understanding of the Course of Non-small Cell Lung Cancer in Patients Undergoing Treatment With Radiotherapy or Chemoradiotherapy

Resource links provided by NLM:


Further study details as provided by AHS Cancer Control Alberta:

Primary Outcome Measures:
  • To determine the relationship between hypoxic changes and the early local tumour response after definitive radiotherapy or chemoradiotherapy in NSCLC [ Time Frame: 2.5 yrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To establish if a correlation exists between 18F-FAZA PET and FluGlucoScan Injection PET in determining responses to definitive treatment in NSCLC [ Time Frame: 2.5 yrs ] [ Designated as safety issue: No ]
  • To assess if patterns of local failure/overall survival correlate with 18F-FAZA PET and/or FluGlucoScan Injection PET [ Time Frame: 7 yrs ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: October 2008
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Patients with inoperable NSCLC undergoing RT or Chemo-RT
Other: 18F-FAZA
Radioactive dose of 110-600 MBq per injection. Up to a maximum of 6 injections per patient: pre-Tx, after 4 weeks (20 fractions) of RT, then 4 weeks, 90 days and 12 months post-RT and upon logo-regional progression or recurrence.
Other Name: NAP
Other: 18F-Fluorodeoxyglucose (18F-FDG)
Radioactive dose of 100-710 MBq per injection. Up to a maximum of 6 injections per patient: pre-Tx, after 4 weeks (20 fractions) RT, then 4 weeks, 90 days, and 12 months post-RT, and upon loco-regional progression or recurrence.
Other Name: FluGlucoScan Injection

Detailed Description:

Locally advanced NSCLC has a poor prognosis with a 5 year overall survival rate of only 15%. Tumour hypoxia may impact the ability to control NSCLC. Using 18F-FAZA PET, this study will assess patients for hypoxic treatment. With this information, we can start individualizing patient treatment to target hypoxia. The relationship between areas of hypoxia (18F-FAZA) and high glucose utilization (18F-FDG) will also be assessed.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with inoperable NSCLC undergoing radiotherapy or chemoradiotherapy

Criteria

Inclusion Criteria:

  1. 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)
  2. 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.
  3. Patients must be deemed to be suitable to undergo definitive (i.e. potentially curable) chemoradiotherapy or radiotherapy by the treating Physician.
  4. The prescribed radiotherapy dose must be a minimum of 60 Gy in 30 fractions
  5. Male or female ≥ 18 years of age. If female of child bearing potential and outside the window of 10 days since the first day of the last menstrual period, a negative pregnancy test is required.
  6. ECOG/Zubrod status 0-1
  7. Patients must have at least one measurable lesion ≥ 1 cm on CT
  8. Able and willing to follow instructions and comply with the protocol
  9. Provide written informed consent prior to participation in the study

Exclusion Criteria:

  1. Patients who have undergone complete or subtotal tumour resection
  2. Patients with post-resection intrathoracic tumour recurrence
  3. Patients eligible for definitive surgery (patients who are eligible for surgery, but surgery did not proceed are eligible for this trial)
  4. No distant or metastasis, prior chemotherapy, or thoracic neck or radiotherapy
  5. Evidence of any small cell histology
  6. Prior or concurrent malignancy (except non-melanomatous skin cancer) unless disease-free for at least 5 years
  7. Inability to lay in supine position for approximately one hour
  8. Nursing or pregnant females
  9. Aged less than 18 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00765986

Contacts
Contact: Lai Schrader 780.432.8464 Lai.Schrader@albertahealthservices.ca

Locations
Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada
Principal Investigator: Dr. Cormac Small, MD         
Sub-Investigator: Dr. A.J.B McEwan, MB         
Sponsors and Collaborators
AHS Cancer Control Alberta
Investigators
Principal Investigator: Dr. Wilson Roa, MD wilson.roa@albertahealthservices.ca
  More Information

No publications provided

Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT00765986     History of Changes
Other Study ID Numbers: LU-24319
Study First Received: October 2, 2008
Last Updated: March 4, 2014
Health Authority: Canada: Health Canada

Keywords provided by AHS Cancer Control Alberta:
18F-FAZA
18F-FDG
Positron Emission Tomography

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Fluorodeoxyglucose F18
Radiopharmaceuticals
Diagnostic Uses of Chemicals
Pharmacologic Actions
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014