Exploratory, Phase 0 Study of Positron Emission Tomography (PET) Imaging Agent, F-18 RGD-K5 (NCT00743353) | Clinical Trial Compass
CompletedEarly Phase 1
Exploratory, Phase 0 Study of Positron Emission Tomography (PET) Imaging Agent, F-18 RGD-K5
United States16 participantsStarted 2008-08
Plain-language summary
The purpose of this research study is to get information from volunteers without cancer and patients with cancer who have received a new investigational study agent called, "\[F-18\] RGDK5," to evaluate biodistribution and dosimetry for the study agent and determine F-18 RGD-K5 uptake in angiogenic tumor. the system.
Who can participate
Age range18 Days
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
For Normal Volunteers
* Subject is ≥ 18 years old at the time of investigational product administration (Subject is male or female of any race / ethnicity)
* Subject or subject's legally acceptable representative provides informed consent
* Subject is capable of complying with study procedures
* Subject is capable of communicating with study personnel
For Cancer Subjects (same first four bullets as 'normals')
* Subject must have had a diagnostic imaging study and is suspected of having a primary or metastatic tumor(s) ( \> 2 cm, except breast tumor)-sarcoma; melanoma; lung cancer \[including small cell and non-small cell lung cancer (NSCL)\]; high grade glioma (including glioblastoma multi-forms), anaplastic astrocytoma, and anaplastic oligodendroglioma; breast carcinomas, and head and neck tumors, including laryngeal squamous cell carcinoma
* Subject is scheduled to have a clinical \[F-18\]FDG PET scan within ± 7 days (with no interventions between the two PET scans) of the investigational, \[F-18\]RGD-K5 PET scan
* Subject is scheduled to undergo resection or biopsy of the target tumor as a result of routine clinical treatment
* Subject has not received any anti-angiogenic agents (e.g. bevacizumab, sorafenib, sunitinib) within 10 days prior to PET/CT imaging
* Subject has laboratory test results within the following ranges:
* AST(SGOT)/ALT(SGPT) ≤ 2.5 x institutional upper limits of normal
* Serum creatinine ≤ 1.5 institutional upper limits of normal…
What they're measuring
1
To collect bio-distribution data to calculate dosimetry values in normals and obtain and evaluate PET images in cancer subjects for resolution of [F-18]RGD-K5