Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT00884520
Eligibility 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00884520
Study Brief:
Protocol Section:
NCT00884520