Back to resultsStudy Using FolateScan to Identify Subjects With Folate Receptor-Positive Metastatic Renal Cell Carcinoma
Primary Purpose
Metastatic Renal Cell Carcinoma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Technetium Tc 99m EC20
Sponsored by
About this trial
This is an interventional other trial for Metastatic Renal Cell Carcinoma focused on measuring Renal Cell
Eligibility Criteria
Inclusion Criteria:
To be eligible for the study, patients must fulfill all of the following criteria:
- Patient must be 18 years of age or older.
- Patient must have suspected metastatic renal cell carcinoma with at least one identifiable lesion >2.0 cm as diagnosed by CT, MRI, or ultrasonography within 60 days prior to enrollment.
- Patient must have good kidney function defined as a serum creatinine ≤1.5 X ULN.
- Patient must provide written informed consent prior to enrollment.
- Patients must provide a formalin-fixed, paraffin-embedded tissue sample of either the primary or metastatic or recurrent site(s) for IHC staining for the presence of folate receptors from either a previous surgical/biopsy procedure or from a surgery/biopsy scheduled within 30 days of FolateScan. A fine needle aspirate is not acceptable.
Exclusion Criteria:
Any of the following criteria will make the patient ineligible to participate in this study:
- 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 or therapeutic chemotherapy 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.
Sites / Locations
- Mayo Clinic
- Baylor College of Medicine
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Technetium Tc 99m EC20
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01689766
Brief Title
Study Using FolateScan to Identify Subjects With Folate Receptor-Positive Metastatic Renal Cell Carcinoma
Official Title
A Screening Study Using FolateScan to Identify Subjects With Folate Receptor-Positive Metastatic Renal Cell Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Endocyte
4. Oversight
5. Study Description
Brief Summary
Phase 2, multi-center, open-label, single-treatment group, baseline-controlled study to identify subjects with Folate Receptor-Positive Metastatic Renal Cell Carcinoma
Detailed Description
The investigational new drug (FolateScan or Technetium Tc 99m EC20) is a folate-targeted diagnostic radiopharmaceutical agent designed to bind to the folate receptor. The folate receptor is a glycoprotein that is over-expressed in many types of cancer cells but it is only minimally distributed in normal tissues . Folate conjugates bind to the folate receptor with high affinity and are brought into the cell via endocytosis. In contrast, folic acid itself enters most normal cells via the reduced folate carrier, a pathway entirely inaccessible to folate conjugates. Therefore, these folate conjugates are specific to cancer cells.
This is a phase 2, multi-center, open-label, single-treatment group, baseline-controlled study designed to verify product safety, gather data on the percentage of metastatic renal cell carcinoma patients with increased uptake of FolateScan in tumors, and to calculate sensitivity, specificity, accuracy, positive predictive value, and negative predictive value of FolateScan compared to immunohistochemical staining (IHC).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Renal Cell Carcinoma
Keywords
Renal Cell
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Technetium Tc 99m EC20
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Technetium Tc 99m EC20
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
To be eligible for the study, patients must fulfill all of the following criteria:
Patient must be 18 years of age or older.
Patient must have suspected metastatic renal cell carcinoma with at least one identifiable lesion >2.0 cm as diagnosed by CT, MRI, or ultrasonography within 60 days prior to enrollment.
Patient must have good kidney function defined as a serum creatinine ≤1.5 X ULN.
Patient must provide written informed consent prior to enrollment.
Patients must provide a formalin-fixed, paraffin-embedded tissue sample of either the primary or metastatic or recurrent site(s) for IHC staining for the presence of folate receptors from either a previous surgical/biopsy procedure or from a surgery/biopsy scheduled within 30 days of FolateScan. A fine needle aspirate is not acceptable.
Exclusion Criteria:
Any of the following criteria will make the patient ineligible to participate in this study:
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 or therapeutic chemotherapy 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.
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study Using FolateScan to Identify Subjects With Folate Receptor-Positive Metastatic Renal Cell Carcinoma
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