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Safety and Efficacy of FalateScan (Technetium Tc 99m EC20) in Patients With Known Suspected Recurrent or Metastatic Cancer From a Solid Tumor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01684098
Recruitment Status : Completed
First Posted : September 12, 2012
Last Update Posted : September 12, 2012
Information provided by (Responsible Party):

Brief Summary:
The folate receptor is over-expressed on many types of cancer cells and new folate receptor targeted therapies are being developed to target cancer cells that over-express the folate receptor. As with other targeted therapies, it is important to develop diagnostic tests that will provide accurate information on folate receptor status and aid in selecting patients that may benefit from folate-targeted therapy.

Condition or disease Intervention/treatment Phase
Recurrent or Metastatic Cancer Head and Neck Cancer Pancreas Cancer Bladder Cancer Testicular Cancer Drug: Tc 99m EC20 Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: 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
Study Start Date : August 2003
Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Tc 99m EC20 Drug: Tc 99m EC20

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 <ULN or alkaline 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01684098

Sponsors and Collaborators
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Principal Investigator: Nelson M Oyesiku, MD, PhD Emory University
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Responsible Party: Endocyte Identifier: NCT01684098    
Other Study ID Numbers: EC20.8
First Posted: September 12, 2012    Key Record Dates
Last Update Posted: September 12, 2012
Last Verified: September 2012
Keywords provided by Endocyte:
recurrent or metastatic cancer
head and neck cancer
pancreas cancer
bladder cancer
testicular cancer
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Urinary Bladder Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Pancreatic Neoplasms
Testicular Neoplasms
Neoplasms by Site
Urologic Neoplasms
Urogenital Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Neoplastic Processes
Pathologic Processes
Digestive System Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Genital Neoplasms, Male
Testicular Diseases
Gonadal Disorders
Technetium Tc 99m-ethylenedicysteine
Molecular Mechanisms of Pharmacological Action