Safety and Efficacy of FalateScan (Technetium Tc 99m EC20) in Patients With Known Suspected Recurrent or Metastatic Cancer From a Solid Tumor
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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. |
ClinicalTrials.gov Identifier: NCT01684098 |
Recruitment Status :
Completed
First Posted : September 12, 2012
Last Update Posted : September 12, 2012
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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 |
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 |

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

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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:
- Patient must be 18 years of age or older.
- 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.
- Patient must have adequate kidney function defined as serum creatinine of < 1.5 X ULN.
- 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.
- Patient must provide written informed consent prior to enrollment.
Exclusion Criteria:
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Patients must be excluded in any of the following conditions are present:
- Patient is pregnant or breastfeeding.
- Patient is simultaneously participating in another investigational drug study, excluding the follow-up phase.
- Patient has received an investigational agent within 7 days prior to enrollment.
- Patient is unable to tolerate conditions for radionuclide imaging.
- Patient has been administered another radiopharmaceutical that would interfere with the assessment of Technetium Tc 99m EC20.

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 ClinicalTrials.gov identifier (NCT number): NCT01684098
Principal Investigator: | Nelson M Oyesiku, MD, PhD | Emory University |
Responsible Party: | Endocyte |
ClinicalTrials.gov 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 |
recurrent or metastatic cancer head and neck cancer pancreas cancer bladder cancer testicular cancer |
Head and Neck Neoplasms Urinary Bladder Neoplasms Neoplasm Metastasis Neoplasms 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 Radiopharmaceuticals Molecular Mechanisms of Pharmacological Action |