Tumour heterogeneity studies based on dedicated breast PET using proliferation radiotracers: early detection of the treatment response

Phase 1

• Conditions: Breast cancer; MedDRA version: 20.0Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2020-000276-38-ES
• Lead Sponsor: Álvaro Ruibal Morell

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-08
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 175

Inclusion Criteria

-Adult women with breast cancer whose therapeutic plan is neoadjuvant chemotherapy
-Negative pregnancy test
-Information Sheet and Informed Consent Form signed by the patient
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 175
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Healthy women
-Women with breast cancer under 18
-Diabetic women with breast cancer
-Pregnant women with breast cancer
-Breast feeding women with breast cancer
-Women with breast cancer who have undergone a surgical procedure
-Women with breast cancer who have received chemotherapy or radiotherapy before the beginning of the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified