Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000593336
Ethics application status
Approved
Date submitted
11/04/2017
Date registered
27/04/2017
Date last updated
29/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot study of 68Ga-Pentixafor positron emission tomography (PET) imaging in multiple myeloma
Scientific title
Pilot study to evaluate the diagnostic accuracy of 68Ga-Pentixafor positron emission tomography (PET) imaging in multiple myeloma
Secondary ID [1] 291579 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 302826 0
Condition category
Condition code
Cancer 302320 302320 0 0
Myeloma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will undergo whole body MRI and 68Ga-Pentixafor PET (68Ga-CPCR4-2) at the Herston Imaging Research Facility (HIRF) at Time point 1 (Diagnosis: prior to, or within 2 weeks of commencing treatment). Participants who have a positive baseline PET will have a second PET/MRI at Timepoint 2 (Post-treatment; minimum 4 weeks/maximum 8 weeks following the cessation of treatment).

A qualified Nuclear Medicine Technologist will insert a tube into a vein and give you an injection of a new 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/MRI is approximately 1hour. After the examination is completed, you will be able to eat and drink normally.
Baseline demographic data will be collected at the time of written informed consent (Study Entry). Follow-up laboratory data will be obtained at Timepoints 1 and 2 by review of the participants’ medical records. Survival data will be collected at 3 monthly intervals by review of the patient medical record until progression, death or for 2 (two) years (whichever occurs earliest).
Intervention code [1] 297755 0
Diagnosis / Prognosis
Comparator / control treatment
Participants will receive a whole body MRI plus or minus whole body radiography dependent on the decisions made by the multidisciplinary team.
Control group
Active

Outcomes
Primary outcome [1] 301729 0
Test accuracy of 68Ga-Pentixafor receptor expression in Multiple Myeloma assessed by 68Ga-Pentixafor PET/MRI Scan.

Timepoint [1] 301729 0
Diagnosis (prior to, or within 2 weeks of commencing treatment) and end of treatment (4-8 weeks following treatment completion)
Primary outcome [2] 301805 0
2. To enable reporting of cases where the index test (PET) detects lesions not apparent on the reference test (WB-MRI), the total lesion pick-up rate will also be reported for each modality.
Timepoint [2] 301805 0
Diagnosis (prior to, or within 2 weeks of commencing treatment) and end of treatment (4-8 weeks following treatment completion)
Secondary outcome [1] 333695 0
Correlation between baseline 68Ga-Pentixafor PET result (positive/negative) and:
1. ISS stage
2. serum LDH at diagnosis
3. FISH results on diagnostic marrow sample
4. plasma cell CXCR4 expression (determined by IHC on diagnostic bone marrow trephine)
Timepoint [1] 333695 0
Diagnosis (prior to, or within 2 weeks of commencing treatment)
Secondary outcome [2] 333908 0
Sensitivity and specificity of 68Ga-Pentixafor PET and WB-MRI for response assessment, using IMWG criteria as reference standard
Timepoint [2] 333908 0
Diagnosis (prior to, or within 2 weeks of commencing treatment) and end of treatment (4-8 weeks following treatment completion)
Secondary outcome [3] 333909 0
Correlation between post-treatment 68Ga-Pentixafor PET results (positive/negative) and
1. ISS stage
2. serum LDH at diagnosis
3. FISH results on diagnostic marrow sample
4. progression-free survival at 2 years.
Timepoint [3] 333909 0
End of treatment (4-8 weeks following treatment completion)

Eligibility
Key inclusion criteria
Inclusion criteria
1. Age >18
2. Able to give informed consent
3. Newly diagnosed or relapsed multiple myeloma, defined by >10% plasma cells on bone marrow biopsy or biopsy-proven plasmacytoma
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria
1. Females of child-bearing potential
2. Males who are unwilling to use an effective contraceptive method
3. Uncontrolled pain which precludes patient from lying supine
4. Patient-reported claustrophobia or anxiety which, in the opinion of the investigator, will prevent patient from completing the imaging procedures
5. Other contraindications to MRI according to institutional policy

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
Recruiting
Date of first participant enrolment
Anticipated
8/05/2017
Actual
24/05/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
6
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 296067 0
Hospital
Name [1] 296067 0
Herston Imaging Research Facility Seed Funding
Country [1] 296067 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital
Address
Royal Brisbane and Women's Hospital
Metro North Hospital and Health Service
Butterfield Street
Herston QLD 4029
Country
Australia
Secondary sponsor category [1] 295070 0
None
Name [1] 295070 0
Address [1] 295070 0
Country [1] 295070 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297323 0
Royal Brisbane and Women's Hospital
Ethics committee address [1] 297323 0
Level 7 Block 7
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029
Ethics committee country [1] 297323 0
Australia
Date submitted for ethics approval [1] 297323 0
31/10/2016
Approval date [1] 297323 0
09/12/2016
Ethics approval number [1] 297323 0

Summary
Brief summary
This study aims to evaluate the performance of 68Ga-Pentixafor positron emission tomography (PET) imaging in a cohort of newly diagnosed and relapsed myeloma patients.

Who is it for?
You may be eligible to join this study if you are aged 18 years or above, and have newly diagnosed or relapsed multiple myeloma, defined by >10% plasma cells on bone marrow biopsy or biopsy-proven plasmacytoma.

Study details
All participants in this study will undergo pentixafor-PET imaging and simultaneous whole-body magnetic resonance imaging (MRI) in a single sitting. The PET scan is the investigational intervention while the MRI scan is the internal control/gold standard. A qualified Nuclear Medicine Technologist will insert a tube into a vein and give you an injection of a new 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/MRI is approximately 1hour. After the examination is completed, you will be able to eat and drink normally.
Participants who have a positive PET will then be asked to undergo a second PET/MRI at the completion of their therapy. The scans will be interpreted using pre-specified criteria by investigators in the Department of Medical Imaging and Department of Nuclear Medicine at the Royal Brisbane Hospital.

We will be examining a) the accuracy of pentixafor-PET compared with whole-body MRI for diagnosing myeloma bone lesions, b) the relationship between PET positivity and conventional disease prognostic markers, and c) the correlation between PET response and conventional biochemical response markers. It is hoped that PET imaging may offer complementary information about disease staging and prognosis, as seen in many other cancers including lymphoma and melanoma.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73706 0
Dr Nicholas Weber
Address 73706 0
Cancer Care Services
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029
Country 73706 0
Australia
Phone 73706 0
+61 7 3646 8111
Fax 73706 0
Email 73706 0
nicholas.weber@health.qld.gov.au
Contact person for public queries
Name 73707 0
Dr Nicholas Weber
Address 73707 0
Cancer Care Services
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029
Country 73707 0
Australia
Phone 73707 0
+61 7 3646 8111
Fax 73707 0
Email 73707 0
nicholas.weber@health.qld.gov.au
Contact person for scientific queries
Name 73708 0
Dr Nicholas Weber
Address 73708 0
Cancer Care Services
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029
Country 73708 0
Australia
Phone 73708 0
+61 7 3646 8111
Fax 73708 0
Email 73708 0
nicholas.weber@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
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