Pentixafor Positron Emission Tomography Scan: A New Imaging Test for Staging in Non-small Cell Lung Cancer

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615001265561
• Date of registration: 19/11/2015
• Prospective Registration: No
• Primary sponsor: Oceanic Molecular Imaging
• Public title: Pentixafor Positron Emission Tomography Scan: A New Imaging Test for Staging in Non-small Cell Lung Cancer
• Scientific title: In patients with Non-Small Cell Lung Cancer (NSCLC) is Pentixafor-PET a more accurate imaging test than FDG-PET for local staging and identifying sites of metastatic disease?
• Date of first enrolment: 02/11/2015
• Target sample size: 30
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12615001265561.aspx
• Study type: Interventional
• Study design: Purpose: Diagnosis; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Efficacy;
• Phase: Phase 1

Countries of recruitment

Australia

Contacts

• Name: Dr Liesl Celliers

• Name: Dr Liesl Celliers

Key inclusion & exclusion criteria

Inclusion criteria: a. Histological diagnosis of NSCLC.
b. Requires 18F-FDG PET/CT as part of routine work-up for diagnosis and staging.
c. Competent to provide informed consent
d. Not pregnant or breastfeeding

Exclusion criteria: Age < 40
Pregnant or breastfeeding
Lack of indication or contraindication to FDG PET

Age minimum: 40 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Non-small cell lung cancer;
Non-small cell lung cancer

Cancer - Lung - Non small cell

Intervention(s)

Participants will have a standard FDG PET scan as part of their cancer staging, as well as a second PET scan using the experimental tracer agent Pentixafor to be scheduled on a separate day within 2 weeks of the first scan. Both the FDG and Pentixafor scans involve insertion of a small intravenous cannula through which a small tracer dose of radioactive tracer is administered. This is followed by hour period of rest (uptake time). Both PET scans will be performed by nuclear imaging technologists at the Hollywood PET Centre. The patient will be required to lie still on the scanner for up to half an hour. The patient needs to fast for 4 hours prior to the scan.

Primary Outcome(s)

To measure and compare maximum Standardized Uptake Value (SUV) in sites of primary and metastatic disease identified on FDG PET and Pentixafor PET.

[Each scan will by double read by reviewed by two qualified radiologists or nuclear medicine specialists on the day of the scan. Tracer uptake quantified using Standardized Uptake Value will be recorded for each site of suspected disease in each patient. ]

Secondary Outcome(s)

To measure the concordance between maximum SUV in sites of disease identified on FDG PET and Pentixafor PET on a lesion by lesion basis for each patient.[Each scan will by double read by reviewed by two qualified radiologists or nuclear medicine specialists on the day of the scan. Concordant and discrepant results between the FDG and Pentixafor PET scans will be recorded in a table. ]

To describe discordant results on FDG PET and Pentixafor on a lesion by lesion basis and correlate with histolopathological results or clinical follow up where this information is available. [Each scan will by double read by reviewed by two qualified radiologists or nuclear medicine specialists on the day of the scan. Concordant and discrepant results between the FDG and Pentixafor PET scans will be recorded in a table. ]

Secondary ID(s)

Nil known

Ethics review

Status: Approved
Approval date:
Contact:

Hollywood Hospital Ethics Committee