NCT00323076

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2006

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 9, 2006

Completed
4 months until next milestone

Study Start

First participant enrolled

September 12, 2006

Completed
12.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2019

Completed
Last Updated

August 26, 2019

Status Verified

February 1, 2019

Enrollment Period

12.4 years

First QC Date

May 5, 2006

Last Update Submit

August 21, 2019

Conditions

Renal Cell CarcinomaNeuroendocrine Tumours

Outcome Measures

Primary Outcomes (1)

  • 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.

    Phase I: 2 years, Phase II: 5 years

Secondary Outcomes (2)

  • Determine the relative tumour uptake of 18F-FAZA

    5 years

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

    5 years

Study Arms (1)

1

EXPERIMENTAL

18F-FAZA PET Imaging

Drug: 18F-FAZA PET Imaging

Interventions

18F-FAZA PET ImagingDRUG

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.

1

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

Related Publications (1)

  • 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.

    PMID: 19430784BACKGROUND

MeSH Terms

Conditions

Carcinoma, Renal CellNeuroendocrine Tumors

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve Tissue

Study Officials

  • Emmanuel W Hudson, MD

    Cross Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2006

First Posted

May 9, 2006

Study Start

September 12, 2006

Primary Completion

February 4, 2019

Study Completion

February 4, 2019

Last Updated

August 26, 2019

Record last verified: 2019-02

Locations

CA(1)