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

NCT00884520 | Completed Early Phase 1

• 1 other identifier: DVM4000
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Conditions

Lung Cancer; Squamous Cell Carcinoma; Head and Neck Cancer; Hepatic Carcinoma; Renal Cell Carcinoma

Keywords

[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

Outcome Measures

Primary Outcomes (1)

• Safety will be the outcome demonstrated in this clinical trial through analyses of adverse events in subjects who receive study drug.

  (3) study visits, including the initial screening visit, the imaging visit, and the 24 hour follow-up visit

Study Arms (1)

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

Interventions

[F-18] VM4-037 DRUG

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.

Also known as: VM4-037

VM4-037

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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 previously received \[F-18\]VM4-037 at any time

Sponsors & Collaborators

• Siemens Molecular Imaging: lead

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Related Publications (1)

• 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.

  PMID: 24696183 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Squamous Cell; Head and Neck Neoplasms; Carcinoma, Hepatocellular; Carcinoma, Renal Cell; Hypoxia

Interventions

3-(4-(2-fluoroethoxy)phenyl)-2-(3-methyl-2-(4-((2-sulfamoylbenzo(d)thiazol-6-yloxy)methyl)-1H-1,2,3-triazol-1-yl)butanamido)propanoic acid

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell; Adenocarcinoma; Liver Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Yu, MD

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 16, 2009
• First Posted: April 20, 2009
• Study Start: April 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: March 16, 2010

Record last verified: 2010-03

Locations

US (1)