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A Phase II Clinical Study to Evaluate the Safety and Efficacy of FalateScan (Technetium Tc 99m EC20) in Patients With Known Suspected Recurrent or Metastatic Cancer From a Solid Tumor


Phase 2
18 Years
N/A
Not Enrolling
Both
Recurrent or Metastatic Cancer, Head and Neck Cancer, Pancreas Cancer, Bladder Cancer, Testicular Cancer

Thank you

Trial Information

A Phase II Clinical Study to Evaluate the Safety and Efficacy of FalateScan (Technetium Tc 99m EC20) in Patients With Known Suspected Recurrent or Metastatic Cancer From a Solid Tumor


This Phase II, limited institution, open-label, single-arm, baseline-controlled study is
designed to obtain data on the percentage of patients with recurrent or metastatic cancer
from a solid tumor (including, but not limited to, breast, lung, mesothelioma, liver,
colorectal, prostate, head and neck, pancreas, bladder and testicular cancer) with increased
uptake of FalateScan in tumors, correlate the immunohistochemical staining findings with the
FolateScan images, and verify product safety in patients with suspected recurrent or
metastatic disease from any solid tumor.


Inclusion Criteria:



- Patients must meet the following eligibility requirements to be enrolled in the
study:

1. Patient must be 18 years of age or older.

2. Patient must have known or strongly suspected recurrent or metastatic cancer
from a solid tumor with at least one identifiable lesion > 1.5 cm as diagnosed
by conventional imaging.

3. Patient must have adequate kidney function defined as serum creatinine of < 1.5
X ULN.

4. Patient must have adequate liver function defined as transaminases (SGOT and/or
SGPT) may be up to 2.5 X ULN if alkaline phosphatase is phosphatase may be up to 2.5 X ULN if Transaminases are < ULN. If alkaline
phosphatase is outside of these parameters and is due to bone metastases
verified by assessment of isoenzymes, then the subject is eligible.

5. Patient must provide written informed consent prior to enrollment.

Exclusion Criteria:

- Patients must be excluded in any of the following conditions are present:

1. Patient is pregnant or breastfeeding.

2. Patient is simultaneously participating in another investigational drug study,
excluding the follow-up phase.

3. Patient has received an investigational agent within 7 days prior to enrollment.

4. Patient is unable to tolerate conditions for radionuclide imaging.

5. Patient has been administered another radiopharmaceutical that would interfere
with the assessment of Technetium Tc 99m EC20.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label

Principal Investigator

Nelson M Oyesiku, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory University

Authority:

United States: Food and Drug Administration

Study ID:

EC20.8

NCT ID:

NCT01684098

Start Date:

August 2003

Completion Date:

August 2005

Related Keywords:

  • Recurrent or Metastatic Cancer
  • Head and Neck Cancer
  • Pancreas Cancer
  • Bladder Cancer
  • Testicular Cancer
  • recurrent or metastatic cancer
  • head and neck cancer
  • pancreas cancer
  • bladder cancer
  • testicular cancer
  • Urinary Bladder Neoplasms
  • Head and Neck Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Pancreatic Neoplasms
  • Testicular Neoplasms

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