FES-PET for Patients Treated on NCI Protocol 8762

NCT01714128 | Withdrawn DMC

• 1 other identifier: Dehdashti FES NCI#9167
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

A significant number of all invasive breast cancers are hormone sensitive and may be candidates for treatment with hormonal therapy. This project will assess the ability and usefulness of imaging hormone-receptor status in breast cancer with positron emission tomography (PET) and 6α-\[18F\]fluoro-17β-estradiol (FES), an estrogen analogue in patients who are scheduled to be treated with hormonal therapy given in combination with a selective allosteric inhibitor of AKT protein kinase (MK2206) .

Conditions

Breast Cancer

Keywords

NCI protocol #8762; Estrogen receptor positive breast cancer; recurrent breast cancer; stage IV breast cancer

Outcome Measures

Primary Outcomes (1)

• FES baseline tumor SUV measurement

  Up to 36 months

Study Arms (1)

Optional Diagnostic Imaging

OTHER

Optional diagnostic imaging FES-PET/CT imaging

Drug: Diagnostic Imaging ( 6α-[18F]fluoro-17β-estradiol (FES))

Interventions

Diagnostic Imaging ( 6α-[18F]fluoro-17β-estradiol (FES)) DRUG

FES-PET/CT imaging

Optional Diagnostic Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have agreed and signed consent to participate in NCI protocol 8762 and be scheduled to receive the first dose of MK-2206 in a minimum of 48 hours and a maximum of 30 days after the FES-PET/CT imaging.
• Note: Patients need to be on the endocrine agent for at least 1 week prior to the FES-PET/CT imaging.
• Patients must have measurable disease (defined by RECIST criteria) or the presence of bone lesions if there is no measurable lesion.
• Patient must be ≥ 18 years of age.
• Patient must be able to tolerate and have no contraindication to FES-PET/CT imaging.
• Patient must be able and willing to give informed consent.

You may not qualify if:

• Patient must have no other active cancer at the time of study entry.
• The research FES-PET/CT scan could not be scheduled more than 48 hours before starting therapy with MK-2206.
• Patient cannot have received treatment for any other malignancy, with the exception of non-melanoma skin cancer, in the past 5 years.
• Patients scheduled to receive chemotherapy as the primary source of treatment

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Mallinckrodt Institute of Radiology

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

X-Rays; proto-oncogene protein c-fes-fps

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Farrokh Dehdashti, M.D.

  Washington Univesity in St. Louis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiology

Study Record Dates

• First Submitted: October 17, 2012
• First Posted: October 25, 2012
• Study Start: June 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 25, 2021

Record last verified: 2021-10

Locations

US (1)