Different Sonographic Modalities and PET-CT in Pediatric Lymphoma

April 22, 2022 updated by: Hager Mohammed Abdelhafiez, Assiut University

Different Sonographic Modalities in Compared With PET-CT in Evaluation of Pediatric Lymphoma

  • To evaluate the accuracy of different sonographic modalities vs PET/CT in assessment of response to therapy in lymphoma patients: both early and late therapeutic response assessment.
  • To evaluate whether imaging features of pathologic lymph nodes on PET/CT and ultrasonography have a predictive role before, during and after treatment in comparison to clinical outcome.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Lymphomas are common malignancies in children [1]. Lymphomas account for about 5% to 6% of all malignancies [2] and include a number of different pathologic subtypes, which arise from the constituent cells of the immune system or from their precursor, lymphoma is now highly treatable. Imaging plays a major role in diagnosis, staging and response making surgical staging unnecessary in most cases [3].

The treatment regimen and the prognosis depend on the morphological type of lymphoma and the disease stage [4].

PET/CT using (18F) FDG is considered one of the functional imaging techniques used to assess the glucose metabolism in vivo; its use has been widely increased in evaluation of oncology patients being highly sensitive in assessment of malignancy as PET/CT can detect malignancy prior to morphological change[5].

Imaging by PET is vastly improved by combining it with CT technology. FDG-PET and CT provide functional and anatomic information, respectively. Integration of both modalities can compensate for the disadvantages of each, and the combination method outperforms , thus PET CT has a proved role for Lymphoma in adult [6].

F-FDG PET/CT is now considered the most accurate imaging modality in the management of adult lymphomas. Its value has been well documented for initial staging, at mid chemotherapy, after the end of therapy, and for assessing tumor recurrence in the follow-up [7,8].

Diagnostic information obtained from 18F-FDG PET scans changed management in 24% of pediatric oncology patients, including those with lymphoma [9].

The sensitivities of FDG-PET for the detection of nodal and extra nodal lesions of lymphoma are 92-100 and 74-78% [10].

The formation of multiple lymph node lesions in distant sites is one of the characteristics differentiating this disease from lymph node metastasis of common cancer, and thus the fact that FDG-PET allows whole-body scanning is a strong point in its favor.[11].

Ultrasonography is an imaging modality that is favored worldwide because of its precision, portability, practicality, and cost. The use of this technology to distinguish metastatic from benign cervical lymph nodes, this determination has implications for diagnosis, staging, and determining optimal treatment regimens [12].

Lymph node enlargement is a common feature of various benign and malignant disorders. It is well recognised that ultrasound is superior to palpation in detecting and characterising subcutaneous lymph nodes, various sonographic modalities can be used for lymph node evaluation, including gray-scale, color Doppler [13].

Nodal sonographic features can offer a clue for whether a lymph node contains cancer. Ultrasound provides detailed information about the internal and external features of a lymph node and demonstrates superior sensitivity and specificity in detecting malignant nodes compared with physical examination [14].

With the use of color Doppler sonography, the vasculature of the lymph nodes can also be evaluated which provides additional information about the nodes. It has become an effective way to obtain more information about the examined lymph nodes with no appreciable increase in the duration or invasiveness of the examination [15].

Study Type

Observational

Enrollment (Anticipated)

45

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 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

Ages Eligible for Study

1 year to 16 years (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Male or female patients. Age: 16 yrs. or younger . Proved lymphoma with histopathology

Description

Inclusion Criteria:

Age: 16 yrs or younger . Proved lymphoma with histopathology

Exclusion Criteria:

Hypersensitivity to 18fluorine FDG Patients

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Different Sonographic Modalities in Compared with PET-CT in Evaluation of Pediatric Lymphoma
Time Frame: baseline
To evaluate the accuracy of different sonographic modalities vs PET/CT in assessment of response to therapy in lymphoma patients
baseline

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Study Director: haisam ahmed samy, professor, Assiut University
  • Study Director: mohamed moamen elbaroudy, doctor, 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

Helpful Links

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)

June 1, 2022

Primary Completion (Anticipated)

August 1, 2023

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

February 11, 2022

First Submitted That Met QC Criteria

April 22, 2022

First Posted (Actual)

April 25, 2022

Study Record Updates

Last Update Posted (Actual)

April 25, 2022

Last Update Submitted That Met QC Criteria

April 22, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • imaging in pediatric lymphoma

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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