The Role of 68GA DOTATATE PET/CT In Breast Cancer Imaging

NCT06359054 | Completed

• 1 other identifier: CelalBayarNRG
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief Summary

Currently, F-18 FDG PET/CT 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 PET/CT 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 ER+/PR+ breast cancer . Its hypothesized that 68Ga DOTATATE PET/CT may be superior to 18F FDG PET/CT 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Comparative Diagnostic Accuracy of 68Ga DOTATATE and 18F FDG PET/CT

  The primary outcome of this study is to assess and compare the diagnostic accuracy of 18F-FDG PET/CT and 68Ga-DOTATATE PET/CT in detecting primary and metastatic breast cancer lesions. This will be evaluated through the identification of lesion uptake patterns, quantified by the maximum standardized uptake value (SUVmax), and the presence of extra-axillary lymph node and distant metastases as indicated by each imaging modality.

  The diagnostic accuracy will be assessed immediately following the completion of both PET/CT scans, with each participant undergoing both scans within a one-week interval. The analysis of images and interpretation of results will occur after all particip

Study Arms (1)

Breast Cancer Patient

EXPERIMENTAL

Diagnostic Test: 18F FDG PET/CT; Diagnostic Test: 68Ga DOTATATE PET/CT

Interventions

18F FDG PET/CT DIAGNOSTIC_TEST

18F-FDG PET/CT Imaging: Preparation: Participants will be instructed to fast for at least 6 hours before the procedure to ensure low insulin levels and high FDG uptake by cancer cells. Radiopharmaceutical Administration: Each participant will receive an intravenous injection of 18F-FDG, dosed at approximately 5.2 MBq/kg (0.14 mCi/kg) of body weight. Imaging Protocol: After the injection, participants will rest in a quiet and dimly lit room for approximately 60 minutes to allow for optimal distribution and uptake of 18F-FDG by the tissues. Subsequently, they will be positioned on the PET/CT scanner bed, and imaging will be performed from the vertex to the proximal thighs. The scan will include a low-dose CT for attenuation correction followed by PET imaging, with the acquisition time adjusted based on the specific protocol (typically 2-3 minutes per bed position).

Breast Cancer Patient

68Ga DOTATATE PET/CT DIAGNOSTIC_TEST

68Ga-DOTATATE PET/CT Imaging: Preparation: No specific fasting is required for 68Ga-DOTATATE PET/CT. However, participants may be advised to hydrate well before the procedure. Radiopharmaceutical Administration: Participants will receive an intravenous injection of 68Ga-DOTATATE, dosed at approximately 2.2 MBq/kg (0.06 mCi/kg) of body weight. Imaging Protocol: Similar to the 18F-FDG protocol, after receiving 68Ga-DOTATATE, participants will wait for about 60 minutes to allow for sufficient uptake of the tracer. They will then undergo PET/CT scanning in a supine position, covering the same body regions as the FDG scan. A low-dose CT scan will be conducted first for attenuation correction, followed by the PET scan, with acquisition parameters tailored to the optimal detection of somatostatin receptor expression.

Breast Cancer Patient

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 to 90 years old
• Performance status: Karnofsky score 70 or better or WHO performance status 2 or better
• Pathologically proven breast cancer by biopsy
• Patients must be able to understand the meaning of the study and sign the appropriate Ethical Committee approved informed consent documents in the presence of the designated staff

You may not qualify if:

• Any medical or psychiatric condition that compromises the subject´s ability to participate in the study
• Any other significant disease including liver or renal disease
• Pregnant or lactating women

Sponsors & Collaborators

• Celal Bayar University: lead

Study Sites (2)

Manisa Celal Bayar University Faculty of Medicine, General Surgery Department

Manisa, 45030, Turkey (Türkiye)

Location

Manisa Celal Bayar University Faculty of Medicine, Nuclear Medicine Department

Manisa, 45030, Turkey (Türkiye)

Location

Related Publications (1)

• Guirguis MS, Adrada BE, Surasi DS, Dryden MJ. 68Ga-DOTATATE Uptake in Primary Breast Cancer. Clin Nucl Med. 2021 Mar 1;46(3):248-249. doi: 10.1097/RLU.0000000000003421.

  PMID: 33234932 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: April 11, 2024
• Study Start: November 11, 2020
• Primary Completion: May 15, 2023
• Study Completion: September 15, 2023
• Last Updated: April 11, 2024

Record last verified: 2024-04

Locations

TU (2)