PET-CT in the Initial Staging of Breast Cancer and in the... | NCT02599974

Studies
PET-CT in the Initial Staging of Breast Cancer and in the Early Assessment of Response to Neoadjuvant Chemotherapy

NCT02599974

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Unknown status

Last Update Posted

Sep 29, 2016Estimated

Enrollment

400Estimated

Phase

Not provided

Conditions

Breast Cancer
Positron-Emission Tomography

Interventions

Not provided

Countries

France

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

Sep 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Dec 2020Estimated

Completion Date

Not provided

First Submitted Date

May 28, 2015

First Submission Date that Met QC Criteria

Nov 6, 2015

First Posted Date

Nov 9, 2015Estimated

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

Sep 28, 2016

Last Update Posted Date

Sep 29, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The two main objectives of this prospective study are:

to identify those patients for whom pre-treatment FDG (Fluorodeoxyglucose) PET (positron emission tomography) CT-scan (Computed tomography scan) provides useful information for the treatment of breast cancer (ASAINT 1),
to improve FDG PET-CT-scan imaging criteria for assessing response to neoadjuvant therapy early, in M0-patients (ASAINT 2).

The secondary objective is to better understand the interactions between the imaging parameters of FDG PET-CT-scan and biological and histological features of breast cancer .

This is a non-interventional study. Two PET-CT-scans are performed, one before starting treatment, and the other after 2 cycles of neoadjuvant chemotherapy. The two PET-CT-scans are prescribed by oncologists from the center of breast diseases Unit at St. Louis hospital, in Paris, France. Oncologists provide clear information to the patients on the purpose of the examination. The examinations are performed in the nuclear medicine department at St. Louis hospital. PET-CT-scans data, tumor characteristics, results of other imaging and biological tests, results of surgery and patient's follow-up are summarized in a "de-identified" file. This file has been declared to the National Commission on Informatics and Liberties (CNIL). The data in this file are established prospectively and secondary analyzed to assess the precise role of PET-CT-scans in the initial staging of breast cancer and to determine the optimal PET-CT-scans criteria to evaluate response to neoadjuvant treatment early.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pathological complete response in M0 patients at baseline PET (stage II-III)	Absence of residual cancer cells in the primary breast tumor and in axillary lymph nodes	18 weeks

Secondary Outcomes

Measure	Description	Time Frame
Number of distant metastases (M1 patients at baseline PET)	Detection of distant metastases by FDG PET-CT	2 weeks
Number of metastatic nodes at baseline PET (axillary and extra-axillary)	Detection of metastatic axillary and extra-axillary nodes by FDG PET-CT

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria :

Histologically confirmed breast cancer
Stage II and III breast cancer
Neo-adjuvant chemotherapy
Baseline PET-CT-scan (ASAINT 1 and 2)
PET-CT-scans after second cycle of neo-adjuvant chemotherapy (ASAINT 2)
Tumor biopsy for diagnosis and biological analysis with hormone receptors and Human Epidermal Growth Factor Receptor-2 (HER2) available
Surgical intervention after completion of neo-adjuvant chemotherapy
Evaluable pathological response

Exclusion Criteria :

Other tumor localization
Non controlled diabetes mellitus
Pregnancy

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

Women with large breast cancer treated with neo-adjuvant chemotherapy regimen.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
David Groheux, MD-PHD	Contact	630603009	+33	david.groheux@sls.aphp.fr
Patricia de Cremoux, MD-PHD	Contact	142499385	+33	patricia.de-cremoux@sls.aphp.fr

Overall Officials

Name	Affiliation	Role
Matthieu Resche-Rigon, MD-PHD	DRCD APHP Paris	Study Chair
David Groheux, MD-PhD	APHP, IUH, University Paris Diderot, Paris 7, SPC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital siant-Louis	Recruiting	Paris	Paris	75010	France

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