NCT05730608

Brief Summary

Purpose To investigate the ability of 18F-FDG PET/CT imaging to detect metastases not detected by conventional imaging (CT and bone scintigraphy) in patients diagnosed with stage II/III and locoregional recurrent breast cancer (BC) which can affect the choice of treatment. Hypothesis The hypothesis is that 18F-FDG PET/CT can provide information about disease stage beyond the currently used conventional imaging (CT and bone scintigraphy) in patients diagnosed with stage II/III or locoregional recurrent BC. Objectives Primary: To evaluate if a 18F-FDG PET/CT scan in the initial work up of patients diagnosed with stage II/III or locoregional recurrent BC will lead to change in staging and/or treatment. Secondary:

  • Overall survival (OS) and progression-free survival (PFS) in the patients with upstaging based on findings on 18F-FDG PET/CT scan compared with the patients with unchanged stage of disease following 18F-FDG PET/CT.
  • Obtain size of the primary BC from CT/MRI scan and evaluate if these metrics are correlated to outcome.
  • Obtain PET parameters from the primary BC: maximum, mean, and peak standardized uptake value (SUVmax, SUVmean, SUVpeak), metabolic tumour volume (MTV), total lesion glycolysis (TLG), total MTV and total TLG and evaluate if these metrics are correlated with outcome.
  • Obtain CT and PET texture parameters from the primary BC and evaluate if these metrics are correlated with outcome.
  • Blood and tumor samples for molecular characterisation:

Trial Health

77
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
81mo left

Started Feb 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress33%
Feb 2023Dec 2032

First Submitted

Initial submission to the registry

January 27, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 16, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

February 16, 2023

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2032

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2032

Last Updated

May 9, 2024

Status Verified

May 1, 2024

Enrollment Period

9.9 years

First QC Date

January 27, 2023

Last Update Submit

May 8, 2024

Conditions

Breast Cancer FemaleBreast Cancer Recurrent

Outcome Measures

Primary Outcomes (1)

  • Change in staging and/or management due to added 18F-FDG PET/CT scan

    Percentage of the patients with change in staging and/or management

    5 years

Secondary Outcomes (1)

  • Overall survival

    5 years

Study Arms (2)

Primary breast cancer

OTHER

Patients diagnosed with new breast cancer determined to have "high risk" disease by a multidisciplinary team.

Other: 18F-FDG PET/CT

Recurrent breast cancer

OTHER

Patients with suspected or proven locoregional recurrent breast cancer.

Other: 18F-FDG PET/CT

Interventions

18F-FDG PET/CTOTHER

Included breast cancer patients will undergo a 18F-FDG PET/CT scan in addition to conventional imaging with CT and bone scintigraphy.

Primary breast cancerRecurrent breast cancer

Eligibility Criteria

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

You may qualify if:

  • Patients with high risk primary or recurrent breast cancer
  • Non pregnant women \> 18 years
  • Not receiving active treatment of other cancer types.
  • Eastern Cooperative Oncology Group (ECOG) status 0-2.

You may not qualify if:

  • Pregnant woman
  • Males
  • Age under 18
  • Patients receiving active treatment for other cancers
  • Poor general conditipon (ECOG 3 or higher)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Drammen Hospital - Vestre Viken HF

Drammen, N-3004, Norway

RECRUITING

Study Officials

  • Harald Grut, MD, PHD

    Vestre Viken Hospital Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Harald Grut, MD, PHD

CONTACT

004797108503harald.grut@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2023

First Posted

February 16, 2023

Study Start

February 16, 2023

Primary Completion (Estimated)

December 31, 2032

Study Completion (Estimated)

December 31, 2032

Last Updated

May 9, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will share

IPD available by request (Harald Grut, harald.grut@gmail.com)

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
10.02.23 to 31.12.32
Access Criteria
IPD available by request (Harald Grut, harald.grut@gmail.com)

Locations

NO(1)