Phase 0 of 18F FPM Using PET/CT in Patients With a Variety of Malignancies

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Cooperative Research Centre for Biomedical Imaging Development
Sponsor:
Information provided by (Responsible Party):
Cooperative Research Centre for Biomedical Imaging Development
ClinicalTrials.gov Identifier:
NCT01755650
First received: December 16, 2012
Last updated: December 19, 2012
Last verified: December 2012
  Purpose

The purpose of this study is to investigate the safety and potential effectiveness of the imaging compound 18F FPM for finding sites of malignancies.


Condition Intervention Phase
Squamous Cell Carcinoma
Radiation: 18F FPM
Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Phase 0 Exploratory Microdosing Study of S-(3-18Ffluoropropyl)Homocysteine Hydrochloride; 18FFPM Using PET/CT in Patients With a Variety of Malignancies.

Resource links provided by NLM:


Further study details as provided by Cooperative Research Centre for Biomedical Imaging Development:

Primary Outcome Measures:
  • 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 [ Time Frame: Up to 28 days following 18F FPM administration (+/- 7 days) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percentage of injected D-18F FPM and L-18F FPM dose in organs of interest. [ Time Frame: 10, 30, 60 and 120 minutes post 18F FPM administration ] [ Designated as safety issue: No ]
  • Percentage of unmetabolized D-18F FPM and L-18F FPM in plasma and urine after radiotracer administration. [ Time Frame: 30 (plasma only) and 90 (plasma and urine) minutes post 18F FPM administration ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 10, 30, 60 and 120 minutes post 18F FPM administration ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: October 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: D-18F FPM Radiation: 18F FPM
Experimental: L-18F FPM Radiation: 18F FPM

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01755650

Contacts
Contact: Sonia Mailer 61 3 9467 6277 sonia.mailer@crcbid.com.au

Locations
Australia, Victoria
Peter MacCallum Cancer Centre Recruiting
East Melbourne, Victoria, Australia
Contact: Ben Solomon    61 3 9656 1111    Ben.Solomon@petermac.org   
Sponsors and Collaborators
Cooperative Research Centre for Biomedical Imaging Development
Investigators
Principal Investigator: Ben Solomon Peter MacCallum Cancer Centre, Australia
  More Information

No publications provided

Responsible Party: Cooperative Research Centre for Biomedical Imaging Development
ClinicalTrials.gov Identifier: NCT01755650     History of Changes
Other Study ID Numbers: 11/31
Study First Received: December 16, 2012
Last Updated: December 19, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Cooperative Research Centre for Biomedical Imaging Development:
18F FPM
PET/CT
microdosing

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell

ClinicalTrials.gov processed this record on October 22, 2014