A Study Using 18F-FAZA and PET Scans to Study Hypoxia in Pancreatic Cancer

NCT01542177 | Completed

• 1 other identifier: FAZA-Pancreas
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a diagnostic study to look for low levels of oxygen (hypoxia) in pancreatic cancer using an imaging test called positron emission tomography (PET). Hypoxia can influence how pancreatic cancer grows and responds to treatments such as chemotherapy and radiotherapy. The use of PET scans to measure hypoxia may be better and simpler than the approaches used previously. This study will assess whether or not PET scans using a tracer called 18F-FAZA (18F-Fluoroazomycin Arabinoside) can provide useful information about hypoxia in pancreatic cancer. Also as part of the study, a blood sample will be taken to study biomarkers (substances in the body that may be important indicators of hypoxia and/or pancreatic cancer) that may be useful in studying pancreatic cancer and hypoxia.

Conditions

Pancreatic Cancer; Hypoxia

Keywords

hypoxia; pancreas; cancer; pancreatic cancer; 18F-FAZA; 18F-Fluoroazomycin Arabinoside; Positron Emission Tomography; PET

Outcome Measures

Primary Outcomes (1)

• Measure the hypoxia level in Patients with Pancreatic Cancer using Positron Emission Tomography (PET) with 18F-Fluoroazomycin Arabinoside (18F-FAZA).

  2 years

Secondary Outcomes (6)

• Correlate FAZA PET uptake in pancreatic cancer with the extension of the disease.

  2 years

• Correlate FAZA PET uptake in pancreatic cancer with CA 19-9 levels.

  2 years

• Correlate FAZA PET uptake in pancreatic cancer with tumor response.

  2 years

• Correlate FAZA PET uptake in pancreatic cancer with patient disease-free survival (DFS).

  2 years

• Compare the pattern of FAZA uptake in different tumor sites (eg., lymph node metastases and liver metastasis).

  2 years

Study Arms (1)

Pancreatic cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Pancreatic cancer

You may qualify if:

• Minimum age of 18 years old
• Histologic diagnosis of pancreatic adenocarcinoma
• TNM (7th edition) cT1-4, N0-1, M0-1
• No cytotoxic anti-cancer therapy for advanced / metastatic pancreatic cancer prior to study entry
• Ability to provide written informed consent to participate in the study
• ECOG performance status 0, 1 or 2.
• Patient should have the following blood counts at baseline: ANC equal or greater to 1.5 x 109/L; Platelets equal or greater to 100 x 109/L; Hgb equal or greater to 9g/Dl
• Patient should have the following blood chemistry levels at baseline: AST (SGOT), ALT (SGPT) equal or less than 5 x upper limit of normal range (ULN) is allowed
• Patient has an identifiable tumor (pancreatic tumor and/or metastasis) by imaging (CT scan and/or MR)
• Patient must agree to use contraception considered adequate and appropriate by the investigator and if the patient is female of child-bearing potential, as evidenced by regular menstrual periods, she must have a negative serum pregnancy test (B-hCG)

You may not qualify if:

• Inability to lie supine for more than 30 minutes
• Any other type of primary cancer
• Life expectancy of less than 12 weeks
• Patient has known brain metastases unless previously treated and well controlled for at least 3 months (defined as stable clinically, no edema, no steroids and stable in two scans at least 4 weeks apart)
• Patient has serious medical risk factors involving any of the major organ systems

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Canadian Cancer Society (CCS): collaborator

Study Sites (1)

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Biospecimen

Retention: NONE RETAINED

2 tubes of whole blood

MeSH Terms

Conditions

Pancreatic Neoplasms; Hypoxia; Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David Hedley, MD

  Princess Margaret Hospital, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2012
• First Posted: March 2, 2012
• Study Start: February 1, 2012
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: May 5, 2022

Record last verified: 2022-05

Locations

CA (1)