NCT01988324

Brief Summary

Knowledge of breast cancer estrogen receptor (ER) expression is of major importance in treatment-decision making. Patients with ER-positive tumors can be treated with anti-oestrogen therapy, which has relatively few side effects compared to chemotherapy. Whole-body tumor ER-expression can be visualized by 18F-fluoroestradiol PET imaging (FES-PET). In addition to ER, the androgen receptor (AR) is a potential new target in breast cancer. PET imaging with 18F-fluorodihydrotestosterone (18F-FDHT) may allow visualization of tumor AR-expression. In the current study we will perform FES-PET and FDHT-PET in metastatic breast cancer patients and evaluate the concordance with concurrent biopsies. Molecular imaging of tumor AR- and ER-expression may well be of value for future treatment decision-making.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

November 1, 2013

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 20, 2013

Completed
8 months until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

May 6, 2024

Status Verified

May 1, 2024

Enrollment Period

1.1 years

First QC Date

November 1, 2013

Last Update Submit

May 3, 2024

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Sensitivity/ specificity

    The concordance between PET (with 18F-FDHT and 18F-FES), and immunohistochemistry (for AR and ER) on concurrent (within 8 weeks) tumor biopsy will be evaluated.

    within two months

Secondary Outcomes (3)

  • Accuracy

    within six weeks

  • Inter- and intra-patient variation

    within six weeks

  • Inter-observer variation

    approximately two months

Study Arms (1)

FES/FDHT-PET

EXPERIMENTAL
Other: FDHT-PET scanOther: FES-PET scanOther: CT-scanOther: Bone scintigraphyOther: Tumor biopsy

Interventions

FDHT-PET scanOTHER
FES/FDHT-PET
FES-PET scanOTHER
FES/FDHT-PET
CT-scanOTHER
FES/FDHT-PET
Bone scintigraphyOTHER
FES/FDHT-PET
Tumor biopsyOTHER
FES/FDHT-PET

Eligibility Criteria

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

You may qualify if:

  • Metastatic breast cancer, with at least one known metastasis outside of the liver
  • Presence of a lesion that is safely accessible for tumor biopsy (may be liver lesion)
  • Postmenopausal status defined as one of the following:
  • age ≥60 years
  • previous bilateral oophorectomy
  • age \<60 years and amenorrhea for \>12 months in the absence of interfering hormonal therapies (such as LH-RH agonists and ER-antagonists)
  • patients age \<60 years using an ER-antagonist should have amenorrhea for \> 12 months and FSH \>24 U/L and LH \>14 U/L e. patient age \<60 years using LH-RH agonists should continue LH-RH-agonists until after the PET procedures
  • Initially ER-positive tumor histology.
  • ECOG performance status 0-2.
  • Signed written informed consent
  • Able to comply with the protocol

You may not qualify if:

  • Use of estrogen receptor ligands, including tamoxifen, fulvestrant or estrogens, or androgen receptor ligands, during the 6 weeks before entry into the study
  • Life-expectancy ≤ 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

VU Medical Center

Amsterdam, Netherlands

Location

University Medical Center Groningen

Groningen, Netherlands

Location

Related Publications (1)

  • Mammatas LH, Venema CM, Schroder CP, de Vet HCW, van Kruchten M, Glaudemans AWJM, Yaqub MM, Verheul HMW, Boven E, van der Vegt B, de Vries EFJ, de Vries EGE, Hoekstra OS, Hospers GAP, der Houven van Oordt CWM. Visual and quantitative evaluation of [18F]FES and [18F]FDHT PET in patients with metastatic breast cancer: an interobserver variability study. EJNMMI Res. 2020 Apr 19;10(1):40. doi: 10.1186/s13550-020-00627-z.

    PMID: 32307594DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

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

Study Record Dates

First Submitted

November 1, 2013

First Posted

November 20, 2013

Study Start

August 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

May 6, 2024

Record last verified: 2024-05

Locations

NL(2)