An Exploratory, Open Label, Multi-Center, Non-Randomized Study of [F-18]VM4-037

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

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 of future studies

Design: Exploratory, open label, nonrandomized, multi-center study

Duration: Three visits - one screening, one imaging, and one follow-up visit at 24 hours post-dose

Procedures: Informed consent, collection of demographic information and medical history, physical examinations, vital signs, 12-lead ECGs, routine blood tests to assess major organ functions, complete blood counts and clinical chemistries for safety, blood sample for CA-IX assay, pre-dose and post-dose blood samples for metabolite analysis, dosing with [F-18]VM4-037, PET imaging scan, dosimetry estimation (normals), urine collections (normals), tumor immunohistochemistry with CA-IX biomarker, follow up to imaging to collect adverse events

Subjects: Approximately sixteen (16) adult subjects including four (4) healthy volunteers and twelve (12) cancer subjects who have confirmed or highly suspected diagnosis of head & neck, lung, large solitary hepatic and renal cell cancer, as defined by protocol criteria

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Siemens Molecular Imaging

Criteria

Inclusion Criteria:

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 Criteria:

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