Status:
COMPLETED
Exploratory, Phase 0 Study of Positron Emission Tomography (PET) Imaging Agent, F-18 RGD-K5
Lead Sponsor:
Siemens Molecular Imaging
Conditions:
Sarcoma
Melanoma
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief 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 evalua...
Detailed Description
\[F-18\]RGD-K5 is being investigated as a diagnostic radiopharmaceutical for the detection and localization of angiogenesis tissue or lesions supporting the application and role of integrins in anti-a...
Eligibility Criteria
Inclusion
- 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
- Platelet count of \> 75,000x106/L
- Hemoglobin value of \> 9 g/dL
- ANC \> 1.2 x 106 /mL
- Exclusion Criteria 'Normals':
- Subject is \< 18 at the time of investigational product administration
- Female subject is pregnant or nursing:
- by testing on site at the institution (serum or urine ßHCG) within 24 hours prior to the investigational product administration
- Subject is unable to remain still for duration of imaging procedure
- Subject has a history of renal disease
- Subject has previously received \[F-18\]RGD-K5 at any time, or any other investigational product in the past 30 days or will receive any other investigational product within 48 hours after the \[F-18\]RGD-K5 injection
- Subject has not been involved in an investigative, radioactive research procedure or therapeutic procedure within the past 6 months
- Subject has any other condition or personal circumstance including severe claustrophobia, severe dyspnea, severe back pain etc, that, in the judgment of the investigator, might interfere with the collection of complete good quality data
- Subject has a history of significant prescription or non-prescription drug, or alcohol abuse, including but not limited to marijuana, cocaine, heroin or derivatives.
- For Cancer Subjects (first three bullets the same as 'normals')
- Subject is \< 18 at the time of investigational product administration
- Female subject is pregnant or nursing:
- by testing on site at the institution (serum or urine ßHCG)
- Subject is unable to remain still for duration of imaging procedure
- Subject has known hyper or hypo-coagulation syndromes. (e.g., Protein C, S deficiency, Hemophilia A/B/C, Factor-V Leiden, etc.)
- Subject has previously received \[F-18\]RGD-K5 at any time, or any other investigational product in the past 30 days or will receive any other investigational product within 48 hours after the \[F-18\]RGD-K5 injection.
- Subject has inadequate tumor size (\< 2 cm , except for breast tumor) or volume to allow for biopsy
- Subject has any other condition or personal circumstance including severe claustrophobia, severe dyspnea, severe back pain etc, that, in the judgment of the investigator, might interfere with the collection of complete good quality data
- Subject has a history of significant prescription or non-prescription drug, or alcohol abuse, including but not limited to marijuana, cocaine, heroin or derivatives.
Exclusion
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2009
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00743353
Start Date
August 1 2008
End Date
January 1 2009
Last Update
February 2 2009
Active Locations (1)
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1
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111