Study Stopped
6 patients were recuited. Due to inability of the tracer to detect regions of interest sufficiently, the trial was closed early.
Phase 0 of 18F FPM Using PET/CT in Patients With a Variety of Malignancies
A Phase 0 Exploratory Microdosing Study of S-(3-18Ffluoropropyl)Homocysteine Hydrochloride; 18FFPM Using PET/CT in Patients With a Variety of Malignancies.
1 other identifier
interventional
6
1 country
1
Brief Summary
The purpose of this study is to investigate the safety and potential effectiveness of the imaging compound 18F FPM for finding sites of malignancies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for early_phase_1
Started Oct 2011
Longer than P75 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 16, 2012
CompletedFirst Posted
Study publicly available on registry
December 24, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 3, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 3, 2017
CompletedSeptember 13, 2023
September 1, 2023
6.1 years
December 16, 2012
September 8, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Up to 28 days following 18F FPM administration (+/- 7 days)
Secondary Outcomes (3)
Percentage of injected D-18F FPM and L-18F FPM dose in organs of interest.
10, 30, 60 and 120 minutes post 18F FPM administration
Percentage of unmetabolized D-18F FPM and L-18F FPM in plasma and urine after radiotracer administration.
30 (plasma only) and 90 (plasma and urine) minutes post 18F FPM administration
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
10, 30, 60 and 120 minutes post 18F FPM administration
Study Arms (2)
D-18F FPM
EXPERIMENTALL-18F FPM
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ben Solomon
Peter MacCallum Cancer Centre, Australia
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2012
First Posted
December 24, 2012
Study Start
October 1, 2011
Primary Completion
November 3, 2017
Study Completion
November 3, 2017
Last Updated
September 13, 2023
Record last verified: 2023-09