An Exploratory, Open Label, Multi-Center, Non-Randomized Study of [F-18]VM4-037
This study has been completed.
Sponsor:
Siemens Molecular Imaging
Information provided by:
Siemens Molecular Imaging
ClinicalTrials.gov Identifier:
NCT00884520
First received: April 16, 2009
Last updated: March 15, 2010
Last verified: March 2010
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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:
|
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
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
| 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, Renal Cell Carcinoma, Squamous Cell Head and Neck Neoplasms Lung Neoplasms Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms |
Neoplasms by Site Kidney Diseases Urologic Diseases Neoplasms, Squamous Cell Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases Liver Neoplasms Digestive System Neoplasms Digestive System Diseases Liver Diseases |
ClinicalTrials.gov processed this record on June 17, 2013