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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Days and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT00743353
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Early Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Siemens Molecular Imaging
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

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

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Sarcoma, Melanoma, Lung Cancer, Breast Cancer, High Grade Gliomas
Additional Details

[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.

Arms & Interventions

Arms

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

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Fox Chase Cancer Center, Philadelphia, Pennsylvania

Status

Address

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111