Exploratory, Phase 0 Study of Positron Emission Tomography (PET) Imaging Agent, F-18 RGD-K5

Breast Cancer Clinical Trial

— K5  

Official title:

An Exploratory, Multi-Center, Open Label, Non-Randomized Study of F-18 RGD-K5

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00743353
• Other study ID #: K5-100
• Status: Completed
• Phase: Phase 0
• First received: August 26, 2008
• Last updated: January 29, 2009
• Start date: August 2008
• Est. completion date: January 2009

Study information

• Verified date: January 2009
• Source: Siemens Molecular Imaging
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer
• High Grade Gliomas
• Lung Cancer
• Melanoma
• Sarcoma

Intervention

Drug:
• F-18 RGD-K5
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

Locations

Country	Name	City	State
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Siemens Molecular Imaging

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		imaging study-participation only days	Yes