NCT00904410

Brief Summary

18F-FDG PET, a whole-body imaging technology based on glucose metabolism, can effectively detect subclinical and clinical therapeutic responses at stages that are earlier than those detected by conventional approaches. We propose to conduct a prospective study to evaluate early therapeutic response using 18F-FDG PET before and after the 1st cycle of neo-adjuvant chemotherapy for breast cancer patients. Variation of 18F-FDG PET uptake is compared to clinical and echographical tumor response evaluated after 3 cycles of chemotherapy. The purpose is to estimate the capacity of 18F-FDG PET to differentiate responder and non-responder patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P25-P50 for phase_4 breast-cancer

Timeline
Completed

Started May 2005

Longer than P75 for phase_4 breast-cancer

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

May 1, 2005

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 15, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

May 19, 2009

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2010

Completed
Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

2.6 years

First QC Date

March 15, 2007

Last Update Submit

March 12, 2026

Conditions

Breast Cancer

Keywords

adenocarcinomabreast

Outcome Measures

Primary Outcomes (1)

  • Variation rate of SUV(BSA max)before and after the 1st cycle of neoadjuvant chemotherapy

    before and 3 weeks after 1st cycle

Secondary Outcomes (1)

  • Comparison to clinical and ultrasound assessment after the 3rd cycle of chemotherapy

    3 weeks after the 3rd cycle

Study Arms (1)

1

EXPERIMENTAL
Other: FDG-PET

Interventions

FDG-PETOTHER

370 MBq of FDG one hour before imaging acquisition PET just before neo-adjuvant chemotherapy and just before the second cycle

1

Eligibility Criteria

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

You may qualify if:

  • Age \> 18
  • Breast cancer treated by neo-adjuvant chemotherapy (T\>2cm)
  • Measurable lesions ,assessed clinically and by ultrasound
  • Delay minimum between biopsy and PET: 15 days
  • PS-WHO: 0

You may not qualify if:

  • T\<2cm
  • Inflammatory breast cancer (T4d)
  • Diabetic patients unbalanced (glycemia\>1.40)
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Oscar Lambret

Lille, 59020, France

Location

MeSH Terms

Conditions

Breast NeoplasmsAdenocarcinoma

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • GAUTHIER Helene

    Centre Oscar Lambret

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2007

First Posted

May 19, 2009

Study Start

May 1, 2005

Primary Completion

December 1, 2007

Study Completion

December 3, 2010

Last Updated

March 13, 2026

Record last verified: 2026-03

Locations

FR(1)