Response Evaluation of Cancer Therapeutics in Metastatic... | NCT06321666

Studies
Response Evaluation of Cancer Therapeutics in Metastatic Breast Cancer to the Bone

NCT06321666

Sponsor

European Institute of Oncology

Status

Unknown status

Last Update Posted

Mar 20, 2024Actual

Enrollment

58Actual

Phase

Not Applicable

Conditions

Metastatic Breast Cancer

Interventions

WB-MRI

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 12, 2019Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Mar 13, 2024

First Submission Date that Met QC Criteria

Mar 13, 2024

First Posted Date

Mar 20, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2024

Last Update Posted Date

Mar 20, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

58Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
WB-MRI and CT Scan	Other	CT scan (neck/thorax/abdomen/pelvis) and WB-MRI	Other: WB-MRI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
WB-MRI	Other	All patients will undergo a CT scan (neck/thorax/abdomen/pelvis) and a WB-MRI	WB-MRI and CT Scan

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Giuseppe Petralia, MD	European Institute of Oncology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IEO Istituto Europeo di Oncologia		Milan		20141	Italy

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided