Recruiting

18F-FAZA

Sponsor:

AHS Cancer Control Alberta

Code:

NCT00765986

Conditions

Lung Neoplasm

Cell Hypoxia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

18F-FAZA

18F-Fluorodeoxyglucose (18F-FDG)

Study Details

Brief summary:

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.

Conditions

Lung Neoplasm

Cell Hypoxia

Study ID

NCT00765986

Start date

Oct, 2008

Status verified date

Oct, 2014

Completion date

Oct, 2015

Anticipated

Primary completion date

Sep, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

1

Patients with inoperable NSCLC undergoing RT or Chemo-RT

Interventions

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.

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Locations

Cross Cancer Institute

Recruiting

Edmonton, Alberta, Canada

Principal Investigator:

Dr. Cormac Small, MD

More Information

Sponsor

AHS Cancer Control Alberta

Last update posted

Oct 3, 2014

Last verified

Oct, 2014

Keywords

  • 18F-FAZA
  • 18F-FDG
  • Positron Emission Tomography

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AHS Cancer Control Alberta on 2014-10-03.