Evaluation of Contrast Enhanced Breast CT for Diagnosis and Staging of Breast Cancer

NCT05404087 | Unknown FDA Device

• 1 other identifier: NL75855.091.21
• Study Type: observational
• Target: 413
• Locations: 0 countries
• Sites: N/A

Brief Summary

Contrast-enhanced breast CT is a novel high resolution and fully 3D imaging method to document abnormalities within the breast. I will establish its value for breast cancer staging and in monitoring therapy response.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Non-inferiority of CEBCT error rate vs DCE MRI error rate, both as compared to the golden standard for tumor staging.

  Non-inferiority of CEBCT error rate against the golden standard, i.e. histopathology, to DCE MRI error rate against the golden standard for tumor staging. i.e. histopathology, to DCE MRI error rate against the golden standard for tumor staging.

  3 years

• Non-inferiority of CEBCT to predict pCR after primary systemic therapy as compared to DCE MRI.

  Non-inferiority of CEBCT to predict pCR after primary systemic therapy as compared to DCE MRI computed from the area under the receiver operating characteristic (ROC) curve (AUC) (or AUROC).

  3 years

Secondary Outcomes (4)

• Concordance of tumor extent between CEBCT and large section histopathology

  3 years

• Frequency of detection of contralateral cancers with CEBCT

  3 years

• Concordance between morphological and enhancement characteristics of cancers on CEBCT to their expected response to primary systemic therapy.

  3 years

• Potential of CEBCT predicting the response to primary systemic therapy early in treatment

  3 years

Study Arms (2)

Pre-operative staging of breast cancer with CEBCT

Women who have been diagnosed with breast cancer and need to have a pre-operative staging and this will be done with contrast-enhanced breast CT.

Device: Dedicated breast CT

Follow-up of women with breast cancer treated with neo-adjuvant chemotherapy

Women who are selected for neo-adjuvant chemotherapy to reduce the size of the tumor need to be followed-up in order to evaluate the treatment response.

Device: Dedicated breast CT

Interventions

Dedicated breast CT DEVICE

Administration of contrast agent and scanning of the breast in order to evaluate the enhancement of the tumor

Follow-up of women with breast cancer treated with neo-adjuvant chemotherapy; Pre-operative staging of breast cancer with CEBCT

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women with breast cancer

You may qualify if:

• Diagnoses of breast cancer
• Scheduled for a pre-surgery staging contrast enhanced breast MRI
• Eligible for primary systemic therapy

You may not qualify if:

• Women with suspected or confirmed pregnancy
• Women with prior history of breast cancer
• Women who are breastfeeding
• Women who are very frail and unable to cooperate
• Women who cannot give informed consent
• Contra indication of iodine contrast (i.e. untreatable contrast allergy, renal function impairment (GFR \<60 ml/min/1.73m2))
• Contra indication for irradiation (i.e. genetic mutation that predispose to breast cancer)
• Male subjects

Sponsors & Collaborators

• Radboud University Medical Center: lead
• The Netherlands Cancer Institute: collaborator

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ritse Mann, MD-PhD

  Radboudumc/The Netherlands Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alma Hoxhaj, MD

CONTACT

+31 24 361 45 45; alma.hoxhaj@radboudumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: June 3, 2022
• Study Start: August 1, 2022
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: June 3, 2022

Record last verified: 2022-05