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Trial registered on ANZCTR


Registration number
ACTRN12615001265561
Ethics application status
Approved
Date submitted
12/11/2015
Date registered
19/11/2015
Date last updated
19/11/2015
Type of registration
Retrospectively registered

Titles & IDs
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?
Secondary ID [1] 287877 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-small cell lung cancer 296763 0
Condition category
Condition code
Cancer 297001 297001 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 293245 0
Diagnosis / Prognosis
Comparator / control treatment
The standard PET scan currently available in Australia uses 18F-FDG which is a radiopharmaceutical used as a generic marker for glucose metabolism and thus is considered an indirect marker of malignancy.
Control group
Active

Outcomes
Primary outcome [1] 296595 0
To measure and compare maximum Standardized Uptake Value (SUV) in sites of primary and metastatic disease identified on FDG PET and Pentixafor PET.

Timepoint [1] 296595 0
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 [1] 318842 0
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.
Timepoint [1] 318842 0
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 outcome [2] 318967 0
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.
Timepoint [2] 318967 0
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.

Eligibility
Key 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
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age < 40
Pregnant or breastfeeding
Lack of indication or contraindication to FDG PET

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 4622 0
Hollywood Private Hospital - Nedlands
Recruitment postcode(s) [1] 12212 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 292373 0
Self funded/Unfunded
Name [1] 292373 0
Address [1] 292373 0
Country [1] 292373 0
Primary sponsor type
Commercial sector/Industry
Name
Oceanic Molecular Imaging
Address
Monash Avenue
Nedlands
WA 6009
Country
Australia
Secondary sponsor category [1] 291099 0
None
Name [1] 291099 0
Address [1] 291099 0
Country [1] 291099 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293847 0
Hollywood Hospital Ethics Committee
Ethics committee address [1] 293847 0
Monash Ave
Nedlands
WA 6009
Ethics committee country [1] 293847 0
Australia
Date submitted for ethics approval [1] 293847 0
10/08/2015
Approval date [1] 293847 0
01/09/2015
Ethics approval number [1] 293847 0
HPH428

Summary
Brief summary
This study aims to determine whether a scan called Pentixafor-PET is a more accurate imaging test than the standard FDG-PET scan in patients with Non-Small Cell Lung Cancer (NSCLC). You may be eligible to join this study if you are aged 40 years or above and have a histological diagnosis of NSCLC and require an 18F-FDG PET/CT as part of routine work-up for diagnosis and staging. All participants in this study 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. This will involve a second scan on a separate day within 2 weeks of the first scan. This will not delay or affect your treatment. If you participate in this trial a small dose of tracer will be administered via a cannula in the arm or hand. There will be a small additional radiation dose from the scan which is unlikely to result in any significant short or long term consequences. The test will usually take less than 2 hours. Results of the two tests will be compared by two specialist doctors in order to determine whether the new Pentixafor-PET scan is more accurate than the FDG-PET scan for local staging and identifying sites of metastatic disease. With your permission the results can be made available to your specialist.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61506 0
A/Prof Nat Lenzo
Address 61506 0
Oceanic Molecular Imaging
Monash Avenue
Nedlands
WA 6009
Country 61506 0
Australia
Phone 61506 0
+618 9386 7800
Fax 61506 0
+618 9386 7888
Email 61506 0
nat.lenzo@health.wa.gov.au
Contact person for public queries
Name 61507 0
Dr Liesl Celliers
Address 61507 0
c/o Oceanic Molecular Imaging
Monash Avenue
Nedlands
WA 6009
Country 61507 0
Australia
Phone 61507 0
+618 9386 7800
Fax 61507 0
+618 9386 7888
Email 61507 0
liesl.celliers@health.wa.gov.au
Contact person for scientific queries
Name 61508 0
Dr Liesl Celliers
Address 61508 0
Oceanic Molecular Imaging
Monash Avenue
Nedlands
WA 6009
Country 61508 0
Australia
Phone 61508 0
+618 9386 7800
Fax 61508 0
+618 9386 7888
Email 61508 0
liesl.celliers@health.wa.gov.au

No information has been provided regarding IPD availability
Summary results
No Results