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

Squamous Cell Carcinoma Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01755650
• Other study ID #: 11/31
• Status: Terminated
• Phase: Early Phase 1
• Start date: October 2011
• Est. completion date: November 3, 2017

Study information

• Verified date: September 2023
• Source: Peter MacCallum Cancer Centre, Australia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: November 3, 2017
• Est. primary completion date: November 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Squamous Cell Carcinoma

Intervention

Radiation:
• 18F FPM

Locations

Country	Name	City	State
Australia	Peter MacCallum Cancer Centre	East Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Peter MacCallum Cancer Centre, Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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