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

September 30, 2021 updated by: SASamy, Assiut University

Correlation Between Petct Based Quantitative Parameters and CA 15.3 in Suspected Recurrent Breast Cancer

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

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

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 22, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 1, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Cpetptmrbc

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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