ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

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]

Nil Known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Rectal Adenocarcinoma

Condition category

Condition code

Cancer

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]

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]

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]

Following the completion of index test (68Ga-CPCR4-2)

Secondary outcome [1]

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]

At time of 68Ga-CPCR4-2 PET/CT tracer scan.

Secondary outcome [2]

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]

Following 68Ga-CPCR4-2 PET/CT tracer scan

Secondary outcome [3]

c) To correlate findings on the 68Ga-CPCR4-2 PET/CT with the histopathology stage of the subsequent surgical specimen;

Timepoint [3]

Following surgical removal of primary rectal adenocarcinomas and loco-regional nodal or any distant metastases.

Secondary outcome [4]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/05/2017

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]

Hospital

Name [1]

Royal Brisbane and Women's Hospital Herston Imaging Research Facility Seed Funding

Address [1]

Metro North Hospital and Health Service
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Brisbane and Women's Hospital

Ethics committee address [1]

Level 7 Block 7
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/11/2016

Approval date [1]

23/12/2016

Ethics approval number [1]

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

Dr Matthew Burge

Address

Cancer Care Services
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029

Country

Australia

Phone

+61 7 3646 8111

Fax

matthew.burge@health.qld.gov.au

Contact person for public queries

Name

Annette Cubitt

Address

Cancer Care Services
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029

Country

Australia

Phone

+61 7 3646 8111

Fax

annette.cubitt@health.qld.gov.au

Contact person for scientific queries

Name

Matthew Burge

Address

Cancer Care Services
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029

Country

Australia

Phone

+61 7 3646 8111

Fax

matthew.burge@health.qld.gov.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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