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


Phase 0
N/A
N/A
Not Enrolling
Both
Sarcoma, Melanoma, Lung Cancer, Breast Cancer, High Grade Gliomas

Thank you

Trial Information

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


[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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

imaging study-participation only days

Safety Issue:

Yes

Principal Investigator

Michael Yu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

United States: Food and Drug Administration

Study ID:

K5-100

NCT ID:

NCT00743353

Start Date:

August 2008

Completion Date:

January 2009

Related Keywords:

  • Sarcoma
  • Melanoma
  • Lung Cancer
  • Breast Cancer
  • High Grade Gliomas
  • laryngeal
  • squamous cell
  • anaplastic astrocytoma
  • oligodendroglioma
  • glioblastoma multiforme
  • Breast Neoplasms
  • Glioma
  • Lung Neoplasms
  • Melanoma
  • Sarcoma

Name

Location

Fox Chase Cancer Center Philadelphia, Pennsylvania  19111