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

Study Overview
=================
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.

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.

Conditions
-----------------
Squamous Cell Carcinoma

Intervention / Treatment
-----------------
* Radiation: 18F FPM


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: D-18F FPM<br> | Radiation: 18F FPM<br> <br> |
| Experimental: L-18F FPM<br> | Radiation: 18F FPM<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
18F FPM, PET/CT, microdosing