NCT01916122

Brief Summary

These are tumors which expresses estrogen receptors. Estrogen receptors are found within breast cancer cells and are an important marker of which medicines may best treat a breast cancer. This study is being performed to imaging the amount of estrogen receptors expressed in the tumor. A research agent named 16α-18F-fluoroestradiol (FES) finds estrogen receptors and binds to them. Then tumors with estrogen receptors can be imaged by a PET/CT scanner, a machine that can take pictures of where the FES is and how much FES is present. The results of this study may help researchers know whether FES can be used to monitor changes in estrogen receptors in tumors during treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P75+ for early_phase_1 breast-cancer

Timeline
Completed

Started Aug 2013

Longer than P75 for early_phase_1 breast-cancer

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

August 1, 2013

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 2, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 5, 2013

Completed
10.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2024

Completed
Last Updated

April 5, 2024

Status Verified

April 1, 2024

Enrollment Period

10.7 years

First QC Date

August 2, 2013

Last Update Submit

April 4, 2024

Conditions

Breast Cancer

Keywords

Fluorestradiol (FES)PET/CT scanEstrogen Receptor13-071

Outcome Measures

Primary Outcomes (1)

  • FES PET/CT scanning

    The objective of this study is only to allow FES PET/CT scanning of patients at MSKCC. This protocol is an "umbrella protocol" to allow FES PET/CT scanning to be used in other companion protocols.

    5 years

Study Arms (1)

(FES) PET/CT for Imaging

EXPERIMENTAL

FES PET/CT studies will be performed as hybrid PET/CT examinations for attenuation correction and lesion localization. A bolus of 5 mCi (+/- 10%) of FES PET/CT will be injected intravenously. 60 (+/- 10) minutes following tracer injection, the patient will be positioned on a GE Discovery PET/CT scanner. A low milliampere CT of from the mid skull to mid thigh will be acquired first, 60-80mAs, 120-140kVp, with a 5mm slice thickness while the patient was free breathing. PET will be acquired at 3-5 minutes per bed position using the 3D mode, approximately 6-7 bed positions. FES PET/CT imaging will take less than 60 minutes. Scans will be reconstructed with iterative reconstruction. If follow-up FES PT/CT scans are performed on a patient, then the same parameters will be used as the initial FES PET/CT scan.

Drug: Fluorestradiol (FES)Procedure: PET/CT Imaging

Interventions

Fluorestradiol (FES)DRUG
(FES) PET/CT for Imaging
PET/CT ImagingPROCEDURE
(FES) PET/CT for Imaging

Eligibility Criteria

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

You may qualify if:

  • Patients with histologic/immunochemical proof of ER+ primary or metastatic malignancy (positive staining in ≥ 1% of cells by immunohistochemistry).
  • Patients who are to be treated with clinically approved or experimental regimens where ER has an important role
  • ECOG performance status of 0-2.
  • Patients must provide written informed consent

You may not qualify if:

  • Age \<18 years
  • Patients who cannot undergo PET/CT scanning (i.e. because of weight limits, claustrophobia)
  • Pregnancy or lactation
  • Total serum bilirubin \> 1.5 times upper limit of normal (abnormal hepatic metabolism may interfere with FES hepatic excretion). Increased serum bilirubin due to Gilbert's syndrome is permitted.
  • Serum creatinine \> 1.5 times upper limit of normal.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Randy Yeh, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2013

First Posted

August 5, 2013

Study Start

August 1, 2013

Primary Completion

April 3, 2024

Study Completion

April 3, 2024

Last Updated

April 5, 2024

Record last verified: 2024-04

Locations

US(1)