Status:
COMPLETED
An Exploratory, Open Label, Multi-Center, Non-Randomized Study of [F-18]VM4-037
Lead Sponsor:
Siemens Molecular Imaging
Conditions:
Lung Cancer
Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
Phase: Exploratory Study Objectives: To collect drug bio-distribution data, begin collection of baseline and tumor/background imaging data, acquire experience to improve study design and the conduct ...
Detailed Description
\[F-18\]VM4-037 is being developed as a diagnostic radiopharmaceutical for PET imaging. SMI is seeking to determine if \[F-18\]VM4-037 might be useful as a PET ligand for the in vivo imaging of CA-IX...
Eligibility Criteria
Inclusion
- Normal Volunteers
- Subject is ≥ 18 years old at the time of investigational product administration, and subject is male or female of any race / ethnicity
- Subject or subject's legally acceptable representative provides written informed consent
- Subject is capable of complying with study procedures
- Subject is capable of communicating with study personnel
- Subject must have renal and hepatic functions and haematological values as defined by laboratory results within defined ranges
- Cancer Subjects
- Subject is ≥ 18 years old at the time of the investigational product administration, and subject is a male or female of any race/ethnicity
- Subject or subject's legally acceptable representative provides written informed consent
- Subject is capable of complying with study procedures
- Subject is capable of communicating with study personnel
- Subject must have renal and hepatic functions and haematological values as defined by laboratory results within defined ranges
- Subject must have confirmed or highly suspected non-small cell lung cancer (local or with metastases), squamous cell carcinoma (advanced stages) of the head and neck whose primary origin was from oral cavity, oropharynx, hypopharynx or larynx (local or with metastases), large solitary hepatic carcinoma (primary or metastatic), or renal cell carcinoma (local or with metastases )
- Subject has an adequate size of tumors (≥2 cm) that should be amenable to imaging and biopsy for immunohistochemistry assay using CA-IX and/or hypoxia biomarkers
- Subject did not have any anticancer treatment intervention between \[F-18\]VM4-037 scan and sampling of biopsied tissue
- Subject is scheduled for a clinical \[F-18\]FDG PET scan within 14 days either prior to or after the investigational, \[F-18\]VM4-037 scan (with no anticancer treatment interventions between the two PET scans)
- Subject has a value of ≥ 60% at the time screening according to the Karnofsky Performance Status Scale
Exclusion
- Normal Volunteers
- Subject is \< 18 years old at the time of investigational product administration
- Subject is nursing
- Female subject is pregnant
- Subject is unable to remain still for duration of imaging procedure
- Subject has a significant hepatic or renal disease as defined by previous medical history or abnormal renal and hepatic functions determined by above lab tests in inclusion criteria
- Subject has previously received \[F-18\]VM4-037 at any time
- Subject has been involved in an investigative, radioactive research procedure within the past 14 days
- Subject has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete data or data quality
- Subject has a history of significant prescription or non-prescription drug, or alcohol abuse, including but not limited to marijuana, cocaine, heroin or derivatives
- Cancer Subjects
- Subject is \< 18 years old at the time of investigational product administration
- Subject is nursing
- Female subject is pregnant
- Subject is unable to remain still for duration of imaging procedure
- Subject has significant hepatic or renal disease as defined by previous medical history or abnormal renal and hepatic functions determined by above lab tests in inclusion criteria
- Subject has previously received \[F-18\]VM4-037 at any time
- Subject has been involved in an investigative, radioactive research procedure within the past 14 days
- Subject has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete data or data quality
- Subject has a history of significant prescription or non-prescription drug, or alcohol abuse, including but not limited to marijuana, cocaine, heroin or derivatives
- Subject has had an anticancer treatment intervention between \[F-18\]VM4-037 scan and biopsied tissue sampling
- Subject has had an anticancer treatment intervention between \[F-18\]VM4-037 scan and \[F-18\]FDG scan
- Subject has an inadequate tumor sites or volume (\< 2 cm) to allow for PET images and biopsy for immunohistochemistry
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2010
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00884520
Start Date
April 1 2009
End Date
March 1 2010
Last Update
March 16 2010
Active Locations (1)
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1
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111