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

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:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label
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

Genetic and Rare Diseases Information Center resources: Kidney Cancer Liver Cancer Renal 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
Study Completion Date:	March 2010
Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Names: [F-18] VM4-037 VM4-037

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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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided by Siemens Molecular Imaging

Additional 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
Study First Received:	April 16, 2009
Last Updated:	March 15, 2010
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

Additional relevant MeSH terms:


Carcinoma Carcinoma, Hepatocellular Carcinoma, Squamous Cell Head and Neck Neoplasms Adenocarcinoma Digestive System Diseases Digestive System Neoplasms	Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell

ClinicalTrials.gov processed this record on March 03, 2015