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IMaging PAtients for Cancer Drug selecTion - Metastatic Breast Cancer

NCT01957332 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 217

Last updated 2024-11-20

No results posted yet for this study

Summary

Current patient work-up, including conventional imaging and pathological assessment of just one single biopsy, might be insufficient to identify metastatic breast cancer patients, who possibly benefit from first-line anti-hormonal or anti-HER2 therapy. As receptor conversion of the tumor is found quite frequently and molecular heterogeneity can occur within one patient, up-to-date whole body information is necessary to determine estrogen receptor (ER) and/or human epidermal growth factor receptor 2 (HER2) receptor status and subsequently guide therapy decision. With molecular imaging via PET this information can be obtained in a non-invasive, patient friendly way. Furthermore, to improve and individualize treatment and be able to identify (new) drug targets and biomarkers, sampling of venous blood, circulating tumor cells (CTC), as well as circulating tumor DNA, microRNA (miRNA) and molecular characterization of one metastasis at the beginning and, if feasible, of an additional biopsy during therapy, is necessary.

Conditions

Interventions

PROCEDURE

Molecular imaging

On the day of FES-injection\&scan or the day after FES-injection, 89Zr-trastuzumab (\~37 MBq) will be injected. The HER2-PET will be performed 4 days after tracerinjection.

PROCEDURE

Molecular imaging

All patients receive 18F-FES (\~200MBq) injection followed by a FES-PET.

Sponsors & Collaborators

  • Amsterdam UMC, location VUmc

    collaborator OTHER

  • University Medical Center Nijmegen

    collaborator OTHER

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • Carolien Schröder, MD, PhD · UMCG

  • Willemien Menke, MD, PhD · VUMC

  • Winette vd Graaf, MD, PhD · RUMC

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-30
Primary Completion
2027-10-31
Completion
2027-10-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01957332 on ClinicalTrials.gov