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Trial registered on ANZCTR


Trial ID
ACTRN12617000596303
Ethics application status
Approved
Date submitted
11/04/2017
Date registered
27/04/2017
Date last updated
27/04/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A Pilot Study of CXCR-4 (68Ga-CPCR4-2) PET (Positron Emission Tomography) scanning in operable rectal cancer
Scientific title
A Pilot Study evaluating the accuracy of CXCR-4 (68Ga-CPCR4-2) PET scanning in operable rectal cancer.
Secondary ID [1] 291671 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rectal Adenocarcinoma 302829 0
Condition category
Condition code
Cancer 302393 302393 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
As part of the clinical trail participants with biopsy proven, newly diagnosed rectal adenocarcinoma, of all clinical stages, will undergo a 68Ga-CPCR4-2 PET scan with a, non contrast, low dose CT (68Ga-CPCR4-2 PET/CT) in one session, at the Herston Imaging Research facility (HIRF).
The PET/CT scan will take approximately 45 mins.
As part of the clinical trial participants will be required to have an extra scan (68Ga-CPCR4-2 PET/CT) on top of the required standard diagnostic evaluations.

A qualified Nuclear Medicine Technologist will administer the 68Ga-CPCR4-2 intravenously and perform the scan and a qualified Nuclear Medicine Physician will interpret the results.

The clinical trial scan will be undertaken when post diagnosis, prior to surgery or any other treatment commencing.

Intervention code [1] 297759 0
Diagnosis / Prognosis
Comparator / control treatment
Standard work up/investigations for this population include a contrast enhanced Pelvic MRI and CT chest, abdomen and pelvis and will have been undertaken as per normal standard of care prior to clinical trial involvement.

Control group
Active

Outcomes
Primary outcome [1] 301733 0
Sensitivity and specificity of 68Ga-CPCR4-2 PET in detecting the spread of primary rectal adencarcinomas, assess by comparison to standard imaging studies (contrast enhanced Pelvic MRI and CT Chest, abdomen and pelvis).

Timepoint [1] 301733 0
Following the completion of index test (68Ga-CPCR4-2)
Secondary outcome [1] 333699 0
a) To measure the uptake of the 68Ga-CPCR4-2 PET/CT tracer, (measured by SUV) in primary rectal adenocarcinomas and loco-regional nodal or any distant metastases;



Timepoint [1] 333699 0
At time of 68Ga-CPCR4-2 PET/CT tracer scan.
Secondary outcome [2] 333897 0
b) To compare the uptake seen of primary rectal tumours and any metastases on 68Ga-CPCR4-2 PET/CT with the findings on standard imaging studies (contrast enhanced Pelvic MRI and CT chest, abdomen and pelvis);
Standard SUV measurement tools used in Nuclear Medicine Reporting will be used to assess uptake.
Timepoint [2] 333897 0
Following 68Ga-CPCR4-2 PET/CT tracer scan
Secondary outcome [3] 333898 0
c) To correlate findings on the 68Ga-CPCR4-2 PET/CT with the histopathology stage of the subsequent surgical specimen;
Timepoint [3] 333898 0
Following surgical removal of primary rectal adenocarcinomas and loco-regional nodal or any distant metastases.
Secondary outcome [4] 333899 0
d) Monitor adverse events of participants receiving 68Ga-CPCR4-2 PET/CT.

The PET/CT procedure:
Common risks and complications include:
1. Minor pain and bruising
Less common risks and complications include:
1. Infection from an intravenous cannula site that may require treatment with antibiotics
2. An allergy to injected drugs may occur, requiring further treatment
Rare risks and complications include:
1. Death as a result of this procedure is very rare

All adverse events reported by the subject/or in response to questioning or observation by the Principal Investigator will be recorded from the time of consent, during the scanning session and for 30 days after the PET scan or until the time of treatment initiation whichever comes first.
Timepoint [4] 333899 0
At time of and for 30 days following (or until treatment initiation) the 68Ga-CPCR4-2 PET/CT tracer scan.

Eligibility
Key inclusion criteria
Inclusion criteria

1) Biopsy proven newly diagnosed rectal adenocarcinoma (of any subtype)

2) Tumour must lie within 15 cm of the anal verge and be below the peritoneal reflection.

3) Age > 18 years

4) Written informed consent

5) All women of child bearing age must have a pregnancy test before enrolment
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

1) Rectal cancer of any other histopathology eg: neuroendocrine, small cell, squamous cell etc.

2) Any other diagnosis of cancer that the investigating team feel might complicate the interpretation of the PET findings.

3) Locally recurrent rectal cancer.

4) Unable to undergo a PET scan, in the opinion of the investigators, for any reason.

5) Pregnant or breast feeding

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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet 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)
QLD

Funding & Sponsors
Funding source category [1] 296170 0
Hospital
Name [1] 296170 0
Royal Brisbane and Women's Hospital Herston Imaging Research Facility Seed Funding
Address [1] 296170 0
Metro North Hospital and Health Service
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029
Country [1] 296170 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital
Address
Metro North Hospital and Health Service
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029
Country
Australia
Secondary sponsor category [1] 295074 0
None
Name [1] 295074 0
Address [1] 295074 0
Country [1] 295074 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297415 0
Royal Brisbane and Women's Hospital
Ethics committee address [1] 297415 0
Level 7 Block 7
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029
Ethics committee country [1] 297415 0
Australia
Date submitted for ethics approval [1] 297415 0
28/11/2016
Approval date [1] 297415 0
23/12/2016
Ethics approval number [1] 297415 0

Summary
Brief summary
This study will compare the accuracy of an investigative imaging technique (known as 68Ga-CPCR4-2 (68Ga-Pentixafor) PET/CT imaging) with conventional staging (contrast enhanced Pelvic MRI and CT chest, abdomen and pelvis) at initial diagnosis of rectal cancer.

Who is it for?
You may be eligible to join this study if you are aged 18 years or above, and have biopsy proven, newly diagnosed rectal adenocarcinoma (of any subtype).

Study details
All participants in this study will undergo a 68Ga-CPCR4-2 (68Ga-Pentixafor) PET scan together with a contemporaneous, non contrast, low dose CT for anatomical correlation, in one session, at the Herston Imaging Research facility (HIRF). A qualified Nuclear Medicine Technologist will insert a tube into a vein in your arm and give you an injection of a radioactive substance called 68Ga-Pentixafor. You will then be required to wait for 1 hour, called the uptake time, before emptying your bladder and proceeding to have your scan. The scan involves lying flat with knees supported and arms resting above your head. You will be scanned from head to mid-thigh. The scan time for the 68Ga-Pentixafor PET/CT will be approximately 45 minutes.

We will monitor all participants for adverse events for 30 days after the PET scan or until the time of treatment initiation whichever comes first. We will also measure the level of tracer uptake by the cancer . If results of this study are promising, we hope to further explore the impact of the PET tracer on management decisions, diagnostic accuracy, as well as the prognostic impact of the uptake of this tracer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73970 0
Dr Matthew Burge
Address 73970 0
Cancer Care Services
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029
Country 73970 0
Australia
Phone 73970 0
+61 7 3646 8111
Fax 73970 0
Email 73970 0
matthew.burge@health.qld.gov.au
Contact person for public queries
Name 73971 0
Ms Annette Cubitt
Address 73971 0
Cancer Care Services
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029
Country 73971 0
Australia
Phone 73971 0
+61 7 3646 8111
Fax 73971 0
Email 73971 0
annette.cubitt@health.qld.gov.au
Contact person for scientific queries
Name 73972 0
Dr Matthew Burge
Address 73972 0
Cancer Care Services
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029
Country 73972 0
Australia
Phone 73972 0
+61 7 3646 8111
Fax 73972 0
Email 73972 0
matthew.burge@health.qld.gov.au