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A Phase 0 Exploratory Microdosing Study of S-(3-18Ffluoropropyl)Homocysteine Hydrochloride; 18FFPM Using PET/CT in Patients With a Variety of Malignancies.


Phase 0
18 Years
N/A
Open (Enrolling)
Both
Squamous Cell Carcinoma

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Trial Information

A Phase 0 Exploratory Microdosing Study of S-(3-18Ffluoropropyl)Homocysteine Hydrochloride; 18FFPM Using PET/CT in Patients With a Variety of Malignancies.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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

Outcome Time Frame:

Up to 28 days following 18F FPM administration (+/- 7 days)

Safety Issue:

Yes

Principal Investigator

Ben Solomon

Investigator Role:

Principal Investigator

Investigator Affiliation:

Peter MacCallum Cancer Centre, Australia

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

11/31

NCT ID:

NCT01755650

Start Date:

October 2011

Completion Date:

July 2013

Related Keywords:

  • Squamous Cell Carcinoma
  • 18F FPM
  • PET/CT
  • microdosing
  • Carcinoma
  • Carcinoma, Squamous Cell

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