Correlation Between PET/CT Parameters and Tumor Markers in Recurrent Breast Cancer

NCT ID: NCT05064475

Last Updated: 2021-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-01

Study Completion Date

2023-05-01

Brief Summary

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Worldwide, breast cancer (BC) is the most frequent type of cancer in women yet, it is associated with relatively lower mortality rates, as it ranks fifth in cancer-related deaths overall, which is attributed to evolution in the treatment of recurrent and metastatic lesions, especially when these lesions were detected early . BC recurrence can occur even 15 years after primary treatment.

Detailed Description

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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

Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

PET/CT

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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PET/CT

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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SASamy

Salma Ahmed Samy anwar

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Salma Ahmed Samy

Role: CONTACT

01069720261

Lamiaa Mahmod eloteify

Role: CONTACT

01001634388

References

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Ayala de la Pena F, Ortiz-Munoz B, Quintanar-Verduguez T, Santotoribio JD, de la Cruz S, Trape-Pujol J, Galve-Calvo E, Auge-Fradera JM, Garcia-Gomez J, Gonzalez-Hernandez A. 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.

Reference Type BACKGROUND
PMID: 33550504 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33708563 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34405063 (View on PubMed)

Stergiou N, Nagel J, Pektor S, Heimes AS, Jakel 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.

Reference Type BACKGROUND
PMID: 31588183 (View on PubMed)

Other Identifiers

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Cpetptmrbc

Identifier Type: -

Identifier Source: org_study_id

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