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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01755650




Registration number
NCT01755650
Ethics application status
Date submitted
16/12/2012
Date registered
24/12/2012
Date last updated
13/09/2023

Titles & IDs
Public title
Phase 0 of 18F FPM Using PET/CT in Patients With a Variety of Malignancies
Scientific title
A Phase 0 Exploratory Microdosing Study of S-(3-18Ffluoropropyl)Homocysteine Hydrochloride; 18FFPM Using PET/CT in Patients With a Variety of Malignancies.
Secondary ID [1] 0 0
11/31
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Squamous Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: D-18F FPM -

Experimental: L-18F FPM -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety of D-18F FPM and L-18F FPM administration as measured by occurrence of adverse clinical, biochemical or haematological events following 18F FPM administration
Timepoint [1] 0 0
Up to 28 days following 18F FPM administration (+/- 7 days)
Secondary outcome [1] 0 0
Percentage of injected D-18F FPM and L-18F FPM dose in organs of interest.
Timepoint [1] 0 0
10, 30, 60 and 120 minutes post 18F FPM administration
Secondary outcome [2] 0 0
Percentage of unmetabolized D-18F FPM and L-18F FPM in plasma and urine after radiotracer administration.
Timepoint [2] 0 0
30 (plasma only) and 90 (plasma and urine) minutes post 18F FPM administration
Secondary outcome [3] 0 0
Absorbed organ doses expressed as micro Sv/MBq of administered D-18F FPM and L-18F FPM, and whole body dose expressed as milliSv/200MBq of administered dose
Timepoint [3] 0 0
10, 30, 60 and 120 minutes post 18F FPM administration

Eligibility
Key inclusion criteria
* Written informed consent obtained prior to any protocol-specific procedures
* Male and female patients with histologically confirmed squamous cell carcinoma
* At least one site of active malignancy, as demonstrated on the pre-study 18F FDG PET/CT scan performed as part of routine clinical care
* Age >/= 18 years
* Life expectancy >/= 3 months
* ECOG Performance score of 0-2
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pregnant or breastfeeding females
* Systemic anti-neoplastic therapy within the 2 weeks prior to the pre-study 18F FDG PET/CT scan until after the 18F FPM PET/CT scan
* Any serious medical condition which the investigator feels may interfere with the procedures or evaluations of the study
* Patients unwilling or unable to comply with protocol or with a history of non-compliance or inability to grant informed consent

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 0
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/11/2017
Sample size
Target
Accrual to date
Final
6
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - East Melbourne
Recruitment postcode(s) [1] 0 0
- East Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Peter MacCallum Cancer Centre, Australia
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ben Solomon
Address 0 0
Peter MacCallum Cancer Centre, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01755650