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

NCT00743353 | Completed Early Phase 1

• 1 other identifier: K5-100
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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 evaluate biodistribution and dosimetry for the study agent and determine F-18 RGD-K5 uptake in angiogenic tumor. the system.

Conditions

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

Keywords

laryngeal; squamous cell; anaplastic astrocytoma; oligodendroglioma; glioblastoma multiforme

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

A

EXPERIMENTAL

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

Interventions

F-18 RGD-K5 DRUG

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

A

Eligibility Criteria

• Age: 18 Days+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Siemens Molecular Imaging: lead

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Related Publications (1)

• Doss M, Kolb HC, Zhang JJ, Belanger MJ, Stubbs JB, Stabin MG, Hostetler ED, Alpaugh RK, von Mehren M, Walsh JC, Haka M, Mocharla VP, Yu JQ. Biodistribution and radiation dosimetry of the integrin marker 18F-RGD-K5 determined from whole-body PET/CT in monkeys and humans. J Nucl Med. 2012 May;53(5):787-95. doi: 10.2967/jnumed.111.088955. Epub 2012 Apr 12.

  PMID: 22499613 DERIVED

MeSH Terms

Conditions

Sarcoma; Melanoma; Lung Neoplasms; Breast Neoplasms; Laryngeal Diseases; Astrocytoma; Oligodendroglioma; Glioblastoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Otorhinolaryngologic Diseases; Glioma; Neoplasms, Neuroepithelial; Neoplasms, Glandular and Epithelial

Study Officials

• Michael Yu, MD

  Fox Chase Cancer Center, Dept of Nuclear Medicine, 333 Cottman Ave, Phila, PA 19111

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 26, 2008
• First Posted: August 28, 2008
• Study Start: August 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: February 2, 2009

Record last verified: 2009-01

Locations

US (1)