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

Sponsored by:	Siemens Molecular Imaging
Information provided by:	Siemens Molecular Imaging
ClinicalTrials.gov Identifier:	NCT00884520

Purpose

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

Condition	Intervention	Phase
Lung Cancer Squamous Cell Carcinoma Head and Neck Cancer Hepatic Carcinoma Renal Cell Carcinoma	Drug: [F-18] VM4-037	Phase 0

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	An Exploratory, Open Label, Multi-Center, Non-Randomized Study of [F-18]VM4-037

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer Lung Cancer

U.S. FDA Resources

Further study details as provided by Siemens Molecular Imaging:

Primary Outcome Measures:

Safety will be the outcome demonstrated in this clinical trial through analyses of adverse events in subjects who receive study drug. [ Time Frame: (3) study visits, including the initial screening visit, the imaging visit, and the 24 hour follow-up visit ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	16
Study Start Date:	April 2009
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
VM4-037: Experimental 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	Drug: [F-18] VM4-037 The individual doses of [F-18]VM4-037 contain a maximum of 20 mCi for normal volunteers and 10 mCi for cancer subjects. The single IP dose is administered to the study subject immediately prior to the start of PET imaging.

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00884520

Contacts

Contact: Ge Zhang, MD, PhD

610-448-3377

G.Zhang@siemens.com

Locations

United States, Pennsylvania
Fox Chase Cancer Center	Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Jian Qin (Michael) Yu, MD 215-728-3021 michael.yu@fccc.edu
Principal Investigator: Michael Yu, MD

Sponsors and Collaborators

Siemens Molecular Imaging

Investigators

Principal Investigator:

Michael Yu, MD

Fox Chase Cancer Center

More Information

No publications provided

Responsible Party:	Siemens Molecular Imaging ( Kirsten Saboe, Clinical Trials Monitor, Clinical Development )
Study ID Numbers:	DVM4000
Study First Received:	April 16, 2009
Last Updated:	April 17, 2009
ClinicalTrials.gov Identifier:	NCT00884520 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Siemens Molecular Imaging:

[F-18]VM4-037
VM4-037
hypoxia
CA-IX
CAIX
carbonic anhydrase IX
hypoxia marker

lung cancer
renal carcinoma
squamous cell carcinoma
hepatic carcinoma
head and neck cancer
advanced stage lung cancer
exploratory

Study placed in the following topic categories:

Thoracic Neoplasms
Urinary Tract Neoplasm
Liver Diseases
Carcinoma, Hepatocellular
Urogenital Neoplasms
Urologic Neoplasms
Squamous Cell Carcinoma
Liver Neoplasms
Renal Cancer
Urologic Diseases
Respiratory Tract Diseases
Kidney Neoplasms
Lung Neoplasms
Kidney Diseases

Neoplasms, Squamous Cell
Hepatocellular Carcinoma
Kidney Cancer
Digestive System Neoplasms
Carcinoma
Digestive System Diseases
Head and Neck Neoplasms
Lung Diseases
Epidermoid Carcinoma
Carcinoma, Renal Cell
Gastrointestinal Neoplasms
Adenocarcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Thoracic Neoplasms
Liver Diseases
Carcinoma, Hepatocellular
Urogenital Neoplasms
Urologic Neoplasms
Liver Neoplasms
Neoplasms by Site
Urologic Diseases
Respiratory Tract Diseases
Kidney Neoplasms
Lung Neoplasms
Kidney Diseases
Neoplasms, Squamous Cell

Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Digestive System Neoplasms
Carcinoma
Neoplasms
Digestive System Diseases
Head and Neck Neoplasms
Lung Diseases
Carcinoma, Renal Cell
Adenocarcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on August 24, 2009