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Trial record 3 of 22 for:    phase0 and michael yu

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

This study has been completed.
Sponsor:
Information provided by:
Siemens Molecular Imaging
ClinicalTrials.gov Identifier:
NCT00884520
First received: April 16, 2009
Last updated: March 15, 2010
Last verified: March 2010
  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:


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

  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
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):
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:
advanced stage lung cancer
[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
exploratory

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

ClinicalTrials.gov processed this record on November 23, 2014