- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00743353
Exploratory, Phase 0 Study of Positron Emission Tomography (PET) Imaging Agent, F-18 RGD-K5 (K5)
An Exploratory, Multi-Center, Open Label, Non-Randomized Study of F-18 RGD-K5
Study Overview
Status
Conditions
Intervention / Treatment
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-angiogenic therapies to benefit patients with cancer and inflammatory diseases.
The primary objectives of this exploratory study are:
- To gain information on biodistribution of [F-18]RGD-K5, and to evaluate the PET images with [F-18]RGD-K5 for resolution, signal to background ratio and for the detection and localization of angiogenesis tissue. This Exploratory Investigational New Drug (EIND) study is designed to obtain preliminary imaging and fundamental biodistribution, metabolism and safety information to demonstrate early proof of concept. The information collected under this study will not be used for diagnostic purposes, to assess the subject's response to therapy, or for clinical management for the subject.
Study Type
Enrollment (Anticipated)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19111
- Fox Chase Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: A
16 subjects to be enrolled; Study Drug F-18 RGD-K5 administered for diagnostic PET Imaging to be observed for a maximum of 4 hours, followed by 24 hour follow up
|
Study Drug F-18 RGD-K5 administered for diagnostic PET Imaging to be observed for a maximum of 4 hours, followed by 24 hour follow up
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
Time Frame: imaging study-participation only days
|
imaging study-participation only days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael Yu, MD, Fox Chase Cancer Center, Dept of Nuclear Medicine, 333 Cottman Ave, Phila, PA 19111
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- K5-100
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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