Response Evaluation of Cancer Therapeutics in Metastatic Breast Cancer to the Bone (RESPECT-MI)

March 13, 2024 updated by: European Institute of Oncology

Response Evaluation of Cancer Therapeutics in Metastatic Breast Cancer to the Bone: A Whole Body MRI Study MILANO : RESPECT-MI

This is a non randomized, single arm study, where each patient will undergo imaging with Computed Tomography (CT) and Whole-body magnetic resonance imaging (WB-MRI) at different timepoint. The primary endpoint is time to progression as documented by CT or WB-MRI.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a monocentric study. All patients will undergo assessments by CT and WB-MRI at all time points.

  • A baseline bone scan or Fluorodeoxyglucose-Position Emission Tomography (FDG-PET) will be performed.
  • CT scans and WB--MRI are performed every 12 weeks until week 96, and then every 24 weeks until disease progression is evident (as defined in section 7.1.3).
  • At the point of disease progression, a repeat bone scan or FDG-PET/CT will be obtained in addition to the CT and WB-MRI. Participation in the trials ends at the point of disease progression.

Patients will be reviewed in outpatient clinic:

  • At baseline
  • Every 12 weeks until week 96, with the results of their recent scans.
  • As with the imaging, the trial visits will change to every 24 weeks after the week 96 visit.

At the week 12 and week 36 visits, the patients will undergo a clinical examination and perform a pain thermometer score and Patient Imaging Questionnaire.

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20141
        • IEO Istituto Europeo di Oncologia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histological diagnosis of breast cancer
  • Single or multiple bone metastases (additional extraosseous or non-bony metastatic disease permitted)
  • Due to start a new line of either hormone therapy or chemotherapy (use of bisphosphonates / denosumab or targeted agents e.g. trastuzumab in addition to hormone therapy / chemotherapy permitted)
  • Aged 18 and over
  • Life expectancy of over 6 months
  • No current active malignancy other than breast cancer

Exclusion Criteria:

  • Radical treatment to sole site of metastatic disease e.g. Cyberknife to solitary bone metastasis
  • Absolute contraindication to MRI studies, CT scans, bone scans or FDG-PET/CT
  • Pregnancy
  • Psychological, familial, sociological or geographical conditions that would hamper compliance with the study protocol; such conditions should be discussed with the patient as part of the informed consent process.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: WB-MRI and CT Scan
CT scan (neck/thorax/abdomen/pelvis) and WB-MRI
Other: WB-MRI
All patients will undergo a CT scan (neck/thorax/abdomen/pelvis) and a WB-MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of disease progression in bone metastasis identified by WB-MRI prior to CT scan
Time Frame: 36 months
Number of patients where disease progression in bone metastases were identified using WB-MRI prior to identification by CT scan
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Institute of Oncology

Investigators

  • Principal Investigator: Giuseppe Petralia, MD, European Institute of Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2019

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

March 13, 2024

First Submitted That Met QC Criteria

March 13, 2024

First Posted (Actual)

March 20, 2024

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IEO 0986

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Metastatic Breast Cancer

Clinical Trials on WB-MRI

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe