Safety and Efficacy of Folatescan (Technetium TC 99M EC20... | NCT01689714

Studies
Safety and Efficacy of Folatescan (Technetium TC 99M EC20) in Patients With Suspected Ovarian Carcinoma or Recurrent Endometrial Carcinoma

NCT01689714

Sponsor

Endocyte

Status

Completed

Last Update Posted

Jun 22, 2023Actual

Enrollment

16Actual

Phase

Phase 2

Conditions

Ovarian Carcinoma
Recurrent Endometrial Carcinoma

Interventions

Tc 99m EC20

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2003

Primary Completion Date

Not provided

Completion Date

Aug 2005Actual

First Submitted Date

Sep 9, 2012

First Submission Date that Met QC Criteria

Sep 17, 2012

First Posted Date

Sep 21, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 20, 2023

Last Update Posted Date

Jun 22, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The folate receptor is overexpressed in many types of cancer, including ovarian and endometrial cancer, and the level of folate receptor expression increases with the stage of the disease. Technetium Tc 99m EC20 (99mTc-EC20; FolateScan), a folate-targeted diagnostic radiopharmaceutical, is designed to bind to the folate receptor. Thus, FolateScan may provide an effective method to determine folate receptor-positive (FR+) target tumors, thereby assisting in the identification of those patients who may benefit from folate-targeted therapy.

Detailed Description

This phase 2, two-center, open-label, single-treatment group, within-patient-controlled study was conducted to:

Expand the safety database and gather data on the percentage of patients with known or suspected ovarian carcinoma or recurrent endometrial carcinoma who show increased uptake of FolateScan in tumors (primary objective).
Calculate the sensitivity, specificity, accuracy, positive predictive value, and negative predictive value of FolateScan compared with immunohistochemical (IHC) staining (secondary objective).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tc 99m EC20	Experimental	Patients received 2 intravenous (IV) injections: 1 mg of folic acid (to reduce the uptake of FolateScan in normal tissues), followed 1 to 3 minutes later by 0.1 mg of EC20 labeled with 15 to 25 mCi of technetium-99m (99mTc) over 30 seconds in a total injection volume of 1 to 2 mL.2 Each injection was given as a slow IV push via a free-flowing indwelling IV catheter in an upper extremity vein (i.e., in the antecubital fossa).	Drug: Tc 99m EC20

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tc 99m EC20	Drug		Tc 99m EC20

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects must meet the following eligibility requirements to be enrolled in the study.
1. Subject must be 18 years of age or older.
2. Subject must have known or strongly suspected ovarian carcinoma or recurrent endometrial carcinoma with at least one identifiable lesion > 1.5 cm as diagnosed by ultrasonography, MRI, or CT.
3. Subject must have good kidney function.
4. Subject must provide written informed consent prior to enrollment.

Exclusion Criteria:

Subjects must be excluded if any of the following conditions are present:
1. Subject is pregnant or breastfeeding.
2. Subject is simultaneously participating in another investigational drug study.
3. Subject has completed the follow-up phase of any previous study less than 30 days prior to enrollment in this study.
4. Subject is unable to tolerate conditions for radionuclide imaging.
5. Subject has been administered another radiopharmaceutical that would interfere with the assessment of Technetium Tc 99m EC20.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Val J Lowe, MD	Mayo Clinic	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D010051	Ovarian Neoplasms
D016889	Endometrial Neoplasms

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases

Browse Leaves

Not provided

Browse Branches

Not provided