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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05064475
Collaborator
(none)
72
19

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: PET/CT

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 Design

Study Type:
Observational
Anticipated Enrollment :
72 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Correlation Between Petct Based Quantitative Parameters and CA 15.3 in Suspected Recurrent Breast Cancer
Anticipated Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Mar 30, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm 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

Diagnostic Test: 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.

Outcome Measures

Primary Outcome Measures

  1. identification of recurrence [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
SASamy, Salma Ahmed Samy anwar, Assiut University
ClinicalTrials.gov Identifier:
NCT05064475
Other Study ID Numbers:
  • Cpetptmrbc
First Posted:
Oct 1, 2021
Last Update Posted:
Oct 1, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 1, 2021