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

Study Description

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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 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 or disease	Intervention/treatment	Phase
Lung Cancer; Squamous Cell Carcinoma; Head and Neck Cancer; Hepatic Carcinoma; Renal Cell Carcinoma	Drug: [F-18] VM4-037	Early Phase 1

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Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	16 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Official Title:	An Exploratory, Open Label, Multi-Center, Non-Randomized Study of [F-18]VM4-037
Study Start Date :	April 2009
Actual Primary Completion Date :	March 2010
Actual Study Completion Date :	March 2010

Arms and Interventions

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Arm	Intervention/treatment
Experimental: VM4-037; 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.; Other Name: VM4-037

Outcome Measures

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Primary Outcome Measures :

1. 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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Locations

United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111

Sponsors and Collaborators

Siemens Molecular Imaging

Investigators

Principal Investigator:	Michael Yu, MD	Fox Chase Cancer Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Doss M, Kolb HC, Walsh JC, Mocharla VP, Zhu Z, Haka M, Alpaugh RK, Chen DY, Yu JQ. Biodistribution and radiation dosimetry of the carbonic anhydrase IX imaging agent [(18) F]VM4-037 determined from PET/CT scans in healthy volunteers. Mol Imaging Biol. 2014 Oct;16(5):739-46. doi: 10.1007/s11307-014-0730-7.

Responsible Party:	Kirsten Saboe, Clinical Trials Monitor, Clinical Development, Siemens Molecular Imaging
ClinicalTrials.gov Identifier:	NCT00884520 History of Changes
Other Study ID Numbers:	DVM4000
First Posted:	April 20, 2009
Last Update Posted:	March 16, 2010
Last Verified:	March 2010

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

Additional relevant MeSH terms:

Carcinoma; Lung Neoplasms; Carcinoma, Squamous Cell; Head and Neck Neoplasms; Carcinoma, Renal Cell; Carcinoma, Hepatocellular; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases	Respiratory Tract Diseases; Neoplasms, Squamous Cell; Adenocarcinoma; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Kidney Diseases; Urologic Diseases; Liver Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases