Viewing Study NCT06359054



Ignite Creation Date: 2024-05-06 @ 8:21 PM
Last Modification Date: 2024-10-26 @ 3:26 PM
Study NCT ID: NCT06359054
Status: COMPLETED
Last Update Posted: 2024-04-11
First Post: 2023-11-06

Brief Title: The Role of 68GA DOTATATE PETCT In Breast Cancer Imaging
Sponsor: Celal Bayar University
Organization: Celal Bayar University

Study Overview

Official Title: The Role of 68GA DOTATATE PETCT In Breast Cancer Imaging a Prospective Study Compared With 18F FDG PETCT
Status: COMPLETED
Status Verified Date: 2024-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Currently F-18 FDG PETCT is routinely used for breast cancer staging and treatment response assessment Most breast cancers express Estrogen Receptor ER and Progesterone Receptor PR and this subtype shows lower activity on FDG imaging 68Ga DOTATATE PETCT is an effective imaging option for somatostatin receptor SSTR positive neuroendocrine tumors There are case reports showing 68Ga DOTATATE uptake in non-Hodgkin lymphoma meningioma breast cancer thyroid adenoma and papillary carcinoma There are also histochemical studies showing that SSTR is a potential radiopharmaceutical target for ERPR breast cancer Its hypothesized that 68Ga DOTATATE PETCT may be superior to 18F FDG PETCT primarily in hormone receptor HR positive breast cancer In this study its aimed to compare the uptake pattern of breast cancer lesions and HR status with 68Ga DOTATATE and 18F FDG uptake in lesions
Detailed Description: This study is designed to explore and compare the uptake patterns of breast cancer lesions using two distinct PETCT imaging modalities 18F-FDG and 68Ga-DOTATATE The primary goal is to assess the diagnostic and prognostic value of these imaging techniques in the context of breast cancer with a particular focus on their ability to inform treatment strategies based on the biological characteristics and stage of the disease

Breast cancer remains the most prevalent cancer among women globally as highlighted by GLOBOCAN 2020 data The diseases treatment involves a multifaceted approach including surgery chemotherapy radiotherapy targeted therapies and endocrine therapy The effectiveness of these treatments is significantly influenced by the tumors biological attributes and its progression stage In this light the accurate pre-treatment staging of breast cancer is paramount with 18F-FDG PETCT playing an increasingly crucial role due to its high accuracy in detecting extra-axillary lymph node metastases and distant metastatic disease

Somatostatin analogs particularly 68Ga-DOTA-TATE have emerged as potent tools for imaging and treating SSTR-positive neuroendocrine tumors leveraging the high affinity of DOTA-TATE for SSTR2 This study extends the application of 68Ga-DOTATATE PETCT to breast cancer motivated by findings that SSTR2 is the most prevalent somatostatin receptor subtype in breast tumors The differential expression of SSTR2 influenced by tumor differentiation and hormonal status underlines the potential of 68Ga-DOTATATE PETCT in providing additional insights into tumor biology

The study will systematically compare the uptake of 18F-FDG and 68Ga-DOTATATE in breast cancer lesions correlating these findings with histopathological subtypes and hormone receptor ER and PR as well as HER2 status By doing so it aims to elucidate the relevance of SSTR2 expression in the heterogeneity of breast cancer and its implications for targeting somatostatin receptors in diagnosis and therapy

This research is expected to contribute significantly to the field of nuclear medicine and oncology by

Providing comparative data on the diagnostic accuracy and prognostic value of 18F-FDG PETCT and 68Ga-DOTATATE PETCT in breast cancer staging

Evaluating the expression of SSTR subtypes in breast cancer and their correlation with tumor histopathology and receptor status

Assessing the potential of 68Ga-DOTATATE PETCT as a complementary tool for the personalized management of breast cancer particularly in cases with somatostatin receptor expression

This study is guided by the latest advancements in molecular imaging and aims to refine breast cancer treatment protocols offering a more tailored and effective approach to patient care

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: None