ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12615000854538

Ethics application status

Approved

Date submitted

6/07/2015

Date registered

17/08/2015

Date last updated

20/07/2016

Type of registration

Retrospectively registered

Titles & IDs

Public title

Pilot Study – Use of [68Ga] gallium-labelled Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET) for the Characterisation of Metastatic Lesions in Patients with Renal Cell Carcinoma

Scientific title

Secondary ID [1]

nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Kidney cancer

Condition category

Condition code

Cancer

Kidney

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

[68Ga]Gallium-labelled Prostate-specific membrane antigen ligand (radio-isotope) will be injected into the blood stream via intravenous access (18-22 Gauge cannula). The dose is 150MBq(5 micrograms). The radio-isotope is used commonly for prostate cancer staging and its safety profile is well documented. The radiation dose is similar to other nuclear medicine studies such as bone scan which are commonly used. After 90 minutes, the participants will be placed in the positron emission tomography (PET) scanner and the scan will begin (scanning takes ~30 minutes). A low dose single phase non-contrast wholebody computed tomography (CT) scan will be performed during the PET scan as this helps to interpret the PET scan. This scan will be undertaken once in the study. The images will be interpreted by a radiologist.

Intervention code [1]

Diagnosis / Prognosis

Intervention code [2]

Early detection / Screening

Comparator / control treatment

As patients would have had multi-phase contrast CT scan as a standard of care/usual care, only a single phase non-contrast CT scan will be performed at the time of PET scan. The multi-phase contrast CT performed previously will be used as a comparator to the PET scan. PET scan is to be performed within 6 weeks of multi-phase CT scan to ensure that there is no bias towards effectiveness of PET scan. In some patients, e.g. those who progress to surgical excision of tumour, specimen may be available for comparison with CT and PET scans.

Control group

Active

Outcomes

Primary outcome [1]

To evaluate the applicability of 68 Ga PSMA PET in detecting metastatic lesions in patients with renal cell carcinoma. The outcome is assessed by comparing the results with standard of care imaging such as CT scan and x-ray. Further, in suitable patients who undergo surgery as a part of standard of care, the histopathology results will be available for comparison.

Timepoint [1]

Within 6weeks of diagnosis and imaging.

Secondary outcome [1]

To assess whether 68 Ga PSMA PET imaging alters treatment decision:
1) If patients are diagnosed with widespread metastatic disease based on the PET imaging, the patient may be treated with chemotherpy/targeted therapy. The outcome will be assessed using hospital records.

Timepoint [1]

Within 6 weeks of diagnosis and imaging.

Secondary outcome [2]

To assess whether 68 Ga PSMA PET imaging alters treatment decision:
2) If patients are diagnosed with oligometastatic disease (<3 lesions) based on the PET imaging, the patient may be referred for the treatment of oligometastatic disease. The outcome will be assessed using hospital records.

Timepoint [2]

Within 6 weeks of diagnosis and imaging

Eligibility

Key inclusion criteria

1. Patients with renal mass larger than 2cm
2. Indeterminant or likely metastatic lesions on staging CT scan
3. No known problems with peripheral intravenous or central line access
4. Able to undergo study imaging within 6 weeks of diagnosis
5. Able to provide informed signed consent

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. Age under 18 years
2. Administered radioisotope within 5 physical half-lives prior to PSMA PET
3. Unable to lie flat during or unable to tolerate PET
4. Prior history of any other malignancy within last 2 years
5. Contraindication to PET scan or 68 Ga PSMA PET ligand
6. Claustrophobia not manageable by oral sedatives. i.e. Temazepam.
7. Renal impairment or haemodialysis.

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)

Patients who are newly diagnosed with locally advanced kidney cancer will be offered a 68 Ga PSMA PET scan as well as conventional CT chest , abdomen and pelvis as part of their staging scans.

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

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

30/07/2015

Actual

30/07/2015

Date of last participant enrolment

Anticipated

31/08/2016

Actual

1/02/2016

Date of last data collection

Anticipated

Actual

15/07/2016

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Princess Alexandra Hospital - Woolloongabba

Recruitment hospital [2]

Greenslopes Private Hospital - Greenslopes

Recruitment postcode(s) [1]

4102 - Woolloongabba

Recruitment postcode(s) [2]

4120 - Greenslopes

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Urology Research Trust Fund, Princess Alexandra Hospital.

Address [1]

237 Ipswich Rd, Woolloongabba QLD 4102

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr Simon Wood

Address

Department of Urology
Princess Alexandra Hospital
237 Ipswich Rd, Woolloongabba QLD 4102

Country

Australia

Secondary sponsor category [1]

None

Name [1]

nil

Address [1]

nil

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Metro South Human Research Ethics Committee

Ethics committee address [1]

Level 7, Translational Research Institute
37 Kent Street, Woolloongabba,
QLD, 4102

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

30/06/2015

Ethics approval number [1]

HREC/15/QPAH/292

Summary

Brief summary

The primary purpose of this study is to determine whether Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET) scan is more sensitive in detecting small metastatic disease in renal cell cancer than conventional computed tomography (CT) scans. 

Who is it for? You may be eligible to join this study if you have been diagnosed with renal cell carcinoma in the past 6 weeks. Study details: All participants will undergo a 68Ga-labelled PSMA PET scan in addition to the standard pf care staging CT scans offered. A standard imaging to diagnose renal cell carcinoma is using multi-phase contrast CT scan which participants would have had for the diagnosis.  The imaging is then compared to PET scan, which involves receiving a radio-isotope via a drip.  This scan is commonly used in prostate cancer staging.  You will be required to have an injection, wait 90 minutes, then lie down on a table inside the PET machine for 30 minutes.  Scans will be assessed for small metastatic disease and patient records will be assessed to determine if the use of PET scan has changed patient management.  It is hoped that the findings of this pilot trial will help to establish whether PSMA PET may be more useful in identifying micrometastases than the CT staging scans alone which are currently being offered. 

In total, all participants of the trial would have had 1 multiphase CT scan to be eligible for referral, and 1 non-contrast single phase CT scan will be performed with 1 PET scan.

Trial website

nil

Trial related presentations / publications

Poster: Rhee H et al. Staging Advanced and Metastatic Clear Cell Renal Cell Carcinoma with 68 Gallium PSMA PET for Treatment Planning. ANZUP, Brisbane. Asia-Pacific Journal of Clinical Oncology, 2016, 12 (3).

Manuscript: Pilot Study: Use of 68 gallium PSMA PET for Detection of Metastatic Lesions in Patients with Primary Renal Tumour. Submitted for publication. Yet to be accepted.

Public notes

Attachments [1]

/AnzctrAttachments/368757-PMSA15.293 HREC Approval.pdf

Contacts

Principal investigator

Name

Dr Simon Wood

Address

Urology & Renal Transplant
Division of Surgery Princess Alexandra Hospital
Metro South Health
Level 4, Building 1, 199 Ipswich Road, Woolloongabba, QLD 4102

Country

Australia

Phone

+61 7 3176 6946

Fax

woodst30@hotmail.com

Contact person for public queries

Name

Handoo Rhee

Address

Urology & Renal Transplant
Division of Surgery Princess Alexandra Hospital
Metro South Health
Level 4, Building 1, 199 Ipswich Road, Woolloongabba, QLD 4102

Country

Australia

Phone

+61 7 3176 6946

Fax

handoorhee@gmail.com

Contact person for scientific queries

Name

Handoo Rhee

Address

Urology & Renal Transplant
Division of Surgery Princess Alexandra Hospital
Metro South Health
Level 4, Building 1, 199 Ipswich Road, Woolloongabba, QLD 4102

Country

Australia

Phone

+61 7 3176 6946

Fax

handoorhee@gmail.com

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

Source	Title	Year of Publication	DOI
Embase	Pilot study: use of gallium-68 PSMA PET for detection of metastatic lesions in patients with renal tumour.	2016	https://dx.doi.org/10.1186/s13550-016-0231-6

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically