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

January 29, 2009 updated by: Siemens Molecular Imaging

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

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.

Study Overview

Status

Completed

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

Interventional

Enrollment (Anticipated)

16

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 weeks and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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

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

This is where you will find people and organizations involved with this study.

Sponsor

Siemens Molecular Imaging

Investigators

  • Principal Investigator: Michael Yu, MD, Fox Chase Cancer Center, Dept of Nuclear Medicine, 333 Cottman Ave, Phila, PA 19111

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (ACTUAL)

January 1, 2009

Study Completion (ACTUAL)

January 1, 2009

Study Registration Dates

First Submitted

August 26, 2008

First Submitted That Met QC Criteria

August 27, 2008

First Posted (ESTIMATE)

August 28, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

February 2, 2009

Last Update Submitted That Met QC Criteria

January 29, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

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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