[18]F-FAZA PET Imaging Study in Patients With Cancer of the Head & Neck, Lung, Renal Cell, Brain, Lymphoma and Neuroendocrine Tumours

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Primary Purpose

Status

Terminated

Phase

Phase 1

Locations

Canada

Study Type

Interventional

Intervention

18F-FAZA PET Imaging

About this trial

This is an interventional diagnostic trial for Renal Cell Carcinoma

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female greater than or equal to 16 years of age. If female of child-bearing potential and outside of the window of 10 days since the first day of the last menstrual period, a negative pregnancy test is required. Patients with known primary or suspected metastatic squamous cell carcinoma of the head and neck, non-small cell or small cell carcinoma of the lung, lymphoma, GBM (greater than or equal to 3 glioma), neuroendocrine tumours, or renal cell carcinoma with at least one lesion >1 cm in diameter.

Sites / Locations

Cross Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

18F-FAZA PET Imaging

Outcomes

Primary Outcome Measures

Phase I: demonstrate the safety of 18F-FAZA manufactured at the Edmonton Radiopharmaceutical Centre/Edmonton PET Centre. Phase II: determine the general biodistribution pattern of18F-FAZA.

Phase I: Pre-injection and post-imaging vital signs, blood haematology and blood chemistry, adverse event collection. Phase II: The location and relative uptake of normal and abnormal 18F-FAZA biodistribution patterns will be determined.

Secondary Outcome Measures

Determine the relative tumour uptake of 18F-FAZA

Measure relative uptake scores (RUS) and tumour to background ratios (T/B) and correlate this uptake to disease progression, disease-free survival, overall survival and response to treatment over 12 months of follow-up.

Confirm the safety of 18F-FAZA manufactured at the Edmonton Radiopharmaceutical Centre/Edmonton PET Centre

Adverse event collection

Full Information

NCT ID

NCT00323076

First Posted

May 5, 2006

Last Updated

August 21, 2019

Sponsor

AHS Cancer Control Alberta

1. Study Identification

Unique Protocol Identification Number

NCT00323076

Brief Title

[18]F-FAZA PET Imaging Study in Patients With Cancer of the Head & Neck, Lung, Renal Cell, Brain, Lymphoma and Neuroendocrine Tumours

Official Title

A Phase I/II Imaging Study of 1-a-D-(5-deoxy-5-[18]F-fluoroarabinofuranosyl)-2-nitroimidazole ([18]F-FAZA) in Patients With Known Squamous Cell Carcinoma of the Head & Neck, Small Cell and Non-Small Cell Carcinoma of the Lung, Lymphoma, Glioblastoma Multiforme, Neuroendocrine Tumours or Renal Cell Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Terminated

Why Stopped

Retirement of former Qualified Investigator and lack of resources to complete study.

Study Start Date

September 12, 2006 (Actual)

Primary Completion Date

February 4, 2019 (Actual)

Study Completion Date

February 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AHS Cancer Control Alberta

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

Positron Emission Tomography (PET) is a Nuclear Medicine procedure that uses positron emitting radiolabeled tracer molecules to visualize biological activity. The presence of hypoxia (low oxygen) is associated with poor prognosis in a variety of tumour types and treatment strategies targeting hypoxic cells have been developed. The PET tracer [18]F-FAZA can identify hypoxic areas, and changes in uptake during treatment may predict tumour response.

Detailed Description

The proposed clinical trial will be a Phase I/II imaging, open label, single site study. In Phase I, one 18F-FAZA PET scan will be conducted in patients with known squamous cell carcinoma of the Head & Neck, SCLC, NSCLC, lymphoma, GGM, neuroendocrine tumours or renal cell carcinoma. In Phase II, three 18F-FAZA PET scans will be done on patients with the above tumours as follows: one pre-treatment, one mid course and one post-treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Cell Carcinoma, Neuroendocrine Tumours

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

92 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1

Arm Type

Experimental

Arm Description

18F-FAZA PET Imaging

Intervention Type

Drug

Intervention Name(s)

18F-FAZA PET Imaging

Intervention Description

Phase I: 110-600 MBq per injection. A single injection of 18F-FAZA and PET scan will be permitted per patient. Phase II: 110-600 MBq per injection. Up to three separate injections of 18F-FAZA and PET scans will be permitted per patient.

Primary Outcome Measure Information:

Title

Phase I: demonstrate the safety of 18F-FAZA manufactured at the Edmonton Radiopharmaceutical Centre/Edmonton PET Centre. Phase II: determine the general biodistribution pattern of18F-FAZA.

Description

Phase I: Pre-injection and post-imaging vital signs, blood haematology and blood chemistry, adverse event collection. Phase II: The location and relative uptake of normal and abnormal 18F-FAZA biodistribution patterns will be determined.

Time Frame

Phase I: 2 years, Phase II: 5 years

Secondary Outcome Measure Information:

Title

Determine the relative tumour uptake of 18F-FAZA

Description

Measure relative uptake scores (RUS) and tumour to background ratios (T/B) and correlate this uptake to disease progression, disease-free survival, overall survival and response to treatment over 12 months of follow-up.

Time Frame

5 years

Title

Confirm the safety of 18F-FAZA manufactured at the Edmonton Radiopharmaceutical Centre/Edmonton PET Centre

Description

Adverse event collection

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Male or female greater than or equal to 16 years of age. If female of child-bearing potential and outside of the window of 10 days since the first day of the last menstrual period, a negative pregnancy test is required. Patients with known primary or suspected metastatic squamous cell carcinoma of the head and neck, non-small cell or small cell carcinoma of the lung, lymphoma, GBM (greater than or equal to 3 glioma), neuroendocrine tumours, or renal cell carcinoma with at least one lesion >1 cm in diameter.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Emmanuel W Hudson, MD

Organizational Affiliation

Cross Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cross Cancer Institute

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1Z2

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

19430784

Citation

Postema EJ, McEwan AJ, Riauka TA, Kumar P, Richmond DA, Abrams DN, Wiebe LI. Initial results of hypoxia imaging using 1-alpha-D: -(5-deoxy-5-[18F]-fluoroarabinofuranosyl)-2-nitroimidazole ( 18F-FAZA). Eur J Nucl Med Mol Imaging. 2009 Oct;36(10):1565-73. doi: 10.1007/s00259-009-1154-5. Epub 2009 May 9.

Results Reference

background

Renal Cell Carcinoma, Neuroendocrine Tumours

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial