NCT01689727

Brief Summary

Many types of cancers overexpress a receptor for the vitamin folate (Folate Receptor). This Phase 2 study will utilize a standard imaging radionuclide, technetium-99m, conjugated to a ligand (EC20) designed to bind to the folate receptor. The study is designed as an open-label, baseline-controlled study.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2004

Completed
8 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 21, 2012

Completed
Last Updated

June 22, 2023

Status Verified

September 1, 2012

Enrollment Period

2 years

First QC Date

September 9, 2012

Last Update Submit

June 20, 2023

Conditions

Pituitary Tumors

Keywords

Pituitary Tumors

Study Arms (1)

Technetium Tc 99m EC20

OTHER
Drug: Technetium Tc 99m EC20

Interventions

Technetium Tc 99m EC20DRUG
Technetium Tc 99m EC20

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects must meet the following eligibility requirements to be enrolled in the study:
  • Subject must be 18 years of age or older.
  • Subject must have a pituitary tumor.
  • Subject must have good kidney function.
  • \. Subject must provide written informed consent prior to enrollment.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory Hospital

Atlanta, Georgia, United States

Location

MeSH Terms

Conditions

Pituitary Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHypothalamic NeoplasmsSupratentorial NeoplasmsBrain NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypothalamic DiseasesPituitary DiseasesEndocrine System Diseases

Study Officials

  • Nelson Oyesiku, MD

    Emory Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2012

First Posted

September 21, 2012

Study Start

September 1, 2002

Primary Completion

September 1, 2004

Last Updated

June 22, 2023

Record last verified: 2012-09

Locations

US(1)