- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05064475
Correlation Between PET/CT Parameters and Tumor Markers in Recurrent Breast Cancer
Correlation Between Petct Based Quantitative Parameters and CA 15.3 in Suspected Recurrent Breast Cancer
Study Overview
Detailed Description
life-long routine monitoring is mandatory. Although histopathologic confirmation is the definitive diagnostic method for BC recurrence, it is not always easy to perform as in cases with deeply located or very small-size lesions, or lesion too close to organs or great vessels, making sampling either inaccessible or hazardous. BC recurrence can be assessed using morphological imaging studies or tumor markers. Mammography, ultrasound (US), computed tomography (CT), and magnetic resonance imaging (MRI) are currently the most commonly used morphological imaging methods for detecting breast cancer recurrence. However, both of the two modalities have some restrictions.
Cancer antigen 15-3 (CA 15-3) and carcinoembryonic antigen (CEA) are two tumor markers that are frequently used in the monitoring of BC patients . However, the findings of many studies on these markers in BC follow-up are conflicting.
The introduction of integrated 2-deoxy-2-[18 F] fluoro-D-glucose (18FDG) positron emission tomography (PET) computed tomography (CT), known as PET/CT, has become a helpful tool for this purpose.
PET/CT is the functional imaging tool that can measure increased glucose metabolism in cancer cells by using 18F-FDG. Its ability to identify tumor recurrence before detection of morphologic changes in conventional imaging reflecting its importance in detecting BC recurrence in asymptomatic patients with high tumor markers and negative results of radiological imaging. 18F-FDG PET/CT is frequently used for BC evaluation. However, data on its value in evaluating BC recurrence in patients with elevated tumor markers are limited and unclear
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Salma Ahmed Samy
- Phone Number: 01069720261
- Email: rehabsamyyy1995@gmail.com
Study Contact Backup
- Name: Lamiaa Mahmod eloteify
- Phone Number: 01001634388
- Email: Lamia_mass@aun.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- female patient with pathologically proved breast cancer who will be referred to do PET\CT imaging at the nuclear medicine unit, Assiut university hospital due to suspicion of recurrence based on elevated level of tumor marker in the period between October 2021 until the end of the study .
Exclusion Criteria:
- patients with newly diagnosed BC patients with early stages of BC BC patients with normal serum level of tumor markers
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Recurrent breast cancer patients with elevated tumor markers
PET/CT is the functional imaging tool that can measure increased glucose metabolism in cancer cells by using 18F-FDG.
Its ability to identify tumor recurrence before detection of morphologic changes in conventional imaging reflecting its importance in detecting BC recurrence in asymptomatic patients with high tumor markers and negative results of radiological imaging.
18F-FDG PET/CT is frequently used for BC evaluation.
However, data on its value in evaluating BC recurrence in patients with elevated tumor markers are limited and unclear
|
Patients with previous breast cancer, already treated and with clinical or biochemical suspicion of disease relapse.
All patients will underwent 18F-fluorodeoxyglucose (FDG) PET/CT.
In all patients, the value of CA 15.3 was compared to PET/CT.
The final diagnosis of relapse will be derived from histopathological sampling As much as possible or radiological follow up for at least 6 months will be compared with PET/CT results.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
identification of recurrence
Time Frame: 2 years
|
correlation between PET/CT parameters and the serum level of tumour markers in suspected recurrent BC as well as finding the best cut-off value of tumor markers that can be used in the identification of recurrence
|
2 years
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Ayala de la Peña F, Ortiz-Muñoz B, Quintanar-Verdúguez T, Santotoribio JD, de la Cruz S, Trapé-Pujol J, Galve-Calvo E, Augé-Fradera JM, García-Gómez J, González-Hernández Á. Consensus of the Spanish society of laboratory medicine and the Spanish society of medical oncology on the methodology and criteria for evaluation of circulating tumour markers in breast cancer. Clin Transl Oncol. 2021 Jul;23(7):1272-1280. doi: 10.1007/s12094-020-02529-x. Epub 2021 Feb 7.
- Liu C, Chen M, Shi Y. Downregulation of hsa_circ_0006220 and its correlation with clinicopathological factors in human breast cancer. Gland Surg. 2021 Feb;10(2):816-825. doi: 10.21037/gs-21-42.
- Khushk M, Khan A, Rehman A, Sheraz S, Tunio YM, Rehman K, Rehman D, Ahmed M, Abbas K, Khan ME. The Role of Tumor Markers: Carcinoembryonic Antigen and Cancer Antigen 15-3 in Patients With Breast Cancer. Cureus. 2021 Jul 10;13(7):e16298. doi: 10.7759/cureus.16298. eCollection 2021 Jul.
- Stergiou N, Nagel J, Pektor S, Heimes AS, Jäkel J, Brenner W, Schmidt M, Miederer M, Kunz H, Roesch F, Schmitt E. Evaluation of a novel monoclonal antibody against tumor-associated MUC1 for diagnosis and prognosis of breast cancer. Int J Med Sci. 2019 Aug 14;16(9):1188-1198. doi: 10.7150/ijms.35452. eCollection 2019.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Cpetptmrbc
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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