Trial Review

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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
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
Secondary ID [1] 286907 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney cancer 295323 0
Condition category
Condition code
Cancer 295595 295595 0 0
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] 292091 0
Diagnosis / Prognosis
Intervention code [2] 292450 0
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] 295302 0
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] 295302 0
Within 6weeks of diagnosis and imaging.
Secondary outcome [1] 315299 0
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] 315299 0
Within 6 weeks of diagnosis and imaging.
Secondary outcome [2] 316241 0
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] 316241 0
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?
No
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
10
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 3918 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 3919 0
Greenslopes Private Hospital - Greenslopes
Recruitment postcode(s) [1] 9836 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 9837 0
4120 - Greenslopes

Funding & Sponsors
Funding source category [1] 291462 0
Hospital
Name [1] 291462 0
Urology Research Trust Fund, Princess Alexandra Hospital.
Country [1] 291462 0
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] 290142 0
None
Name [1] 290142 0
nil
Address [1] 290142 0
nil
Country [1] 290142 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293128 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 293128 0
Level 7, Translational Research Institute
37 Kent Street, Woolloongabba,
QLD, 4102
Ethics committee country [1] 293128 0
Australia
Date submitted for ethics approval [1] 293128 0
Approval date [1] 293128 0
30/06/2015
Ethics approval number [1] 293128 0
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] 520 520 0 0
/AnzctrAttachments/368757-PMSA15.293 HREC Approval.pdf

Contacts
Principal investigator
Name 58086 0
Dr Simon Wood
Address 58086 0
Urology & Renal Transplant
Division of Surgery Princess Alexandra Hospital
Metro South Health
Level 4, Building 1, 199 Ipswich Road, Woolloongabba, QLD 4102
Country 58086 0
Australia
Phone 58086 0
+61 7 3176 6946
Fax 58086 0
Email 58086 0
woodst30@hotmail.com
Contact person for public queries
Name 58087 0
Dr Handoo Rhee
Address 58087 0
Urology & Renal Transplant
Division of Surgery Princess Alexandra Hospital
Metro South Health
Level 4, Building 1, 199 Ipswich Road, Woolloongabba, QLD 4102
Country 58087 0
Australia
Phone 58087 0
+61 7 3176 6946
Fax 58087 0
Email 58087 0
handoorhee@gmail.com
Contact person for scientific queries
Name 58088 0
Dr Handoo Rhee
Address 58088 0
Urology & Renal Transplant
Division of Surgery Princess Alexandra Hospital
Metro South Health
Level 4, Building 1, 199 Ipswich Road, Woolloongabba, QLD 4102
Country 58088 0
Australia
Phone 58088 0
+61 7 3176 6946
Fax 58088 0
Email 58088 0
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
SourceTitleYear of PublicationDOI
EmbasePilot study: use of gallium-68 PSMA PET for detection of metastatic lesions in patients with renal tumour.2016https://dx.doi.org/10.1186/s13550-016-0231-6
N.B. These documents automatically identified may not have been verified by the study sponsor.