NCT05343676

Brief Summary

  • 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 25, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

April 25, 2022

Status Verified

April 1, 2022

Enrollment Period

1.2 years

First QC Date

February 11, 2022

Last Update Submit

April 22, 2022

Conditions

Pediatric Lymphoma

Outcome Measures

Primary Outcomes (1)

  • 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

    baseline

Interventions

ultrasonographyDEVICE

* For assessment of LNS ( cervical , axillary and inguinal LNS ), The choice of transducer is an important consideration when evaluating lymph nodes as higher frequencies provide better resolution for superficial structures * For color Doppler assessment of the lymph nodes, scanning will be done using the slow frame rate, low pulse repetition frequency * Assessment features including lymph node location, size, shape, border, echogenicity, calcifications, necrosis or cystic change, and adjacent soft tissue edema

Eligibility Criteria

Age1 Year - 16 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Age: 16 yrs or younger . Proved lymphoma with histopathology

You may not qualify if:

  • Hypersensitivity to 18fluorine FDG Patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (12)

  • McCarten KM, Nadel HR, Shulkin BL, Cho SY. Imaging for diagnosis, staging and response assessment of Hodgkin lymphoma and non-Hodgkin lymphoma. Pediatr Radiol. 2019 Oct;49(11):1545-1564. doi: 10.1007/s00247-019-04529-8. Epub 2019 Oct 16.

    PMID: 31620854BACKGROUND

  • Gupta A, Rahman K, Shahid M, Kumar A, Qaseem SM, Hassan SA, Siddiqui FA. Sonographic assessment of cervical lymphadenopathy: role of high-resolution and color Doppler imaging. Head Neck. 2011 Mar;33(3):297-302. doi: 10.1002/hed.21448.

    PMID: 20652889BACKGROUND

  • Giacomini CP, Jeffrey RB, Shin LK. Ultrasonographic evaluation of malignant and normal cervical lymph nodes. Semin Ultrasound CT MR. 2013 Jun;34(3):236-47. doi: 10.1053/j.sult.2013.04.003.

    PMID: 23768890BACKGROUND

  • Elshikh M, Moawad AW, Salem U, Klimkowski SP, Hassan T, Rao Korivi B, Jensen CT, Javadi S, Elsayes KM. Oncologic Imaging of the Lymphatic System: Current Perspective with Multi-Modality Imaging and New Horizon. Cancers (Basel). 2021 Sep 10;13(18):4554. doi: 10.3390/cancers13184554.

    PMID: 34572781BACKGROUND

  • Kleis M, Daldrup-Link H, Matthay K, Goldsby R, Lu Y, Schuster T, Schreck C, Chu PW, Hawkins RA, Franc BL. Diagnostic value of PET/CT for the staging and restaging of pediatric tumors. Eur J Nucl Med Mol Imaging. 2009 Jan;36(1):23-36. doi: 10.1007/s00259-008-0911-1. Epub 2008 Aug 22.

    PMID: 18719909BACKGROUND

  • Kostakoglu L, Leonard JP, Kuji I, Coleman M, Vallabhajosula S, Goldsmith SJ. Comparison of fluorine-18 fluorodeoxyglucose positron emission tomography and Ga-67 scintigraphy in evaluation of lymphoma. Cancer. 2002 Feb 15;94(4):879-88.

    PMID: 11920454BACKGROUND

  • Jerusalem G, Beguin Y, Fassotte MF, Belhocine T, Hustinx R, Rigo P, Fillet G. Early detection of relapse by whole-body positron emission tomography in the follow-up of patients with Hodgkin's disease. Ann Oncol. 2003 Jan;14(1):123-30. doi: 10.1093/annonc/mdg011.

    PMID: 12488304BACKGROUND

  • Wegner EA, Barrington SF, Kingston JE, Robinson RO, Ferner RE, Taj M, Smith MA, O'Doherty MJ. The impact of PET scanning on management of paediatric oncology patients. Eur J Nucl Med Mol Imaging. 2005 Jan;32(1):23-30. doi: 10.1007/s00259-004-1645-3. Epub 2004 Jul 31.

    PMID: 15290124BACKGROUND

  • Yamamoto F, Tsukamoto E, Nakada K, Takei T, Zhao S, Asaka M, Tamaki N. 18F-FDG PET is superior to 67Ga SPECT in the staging of non-Hodgkin's lymphoma. Ann Nucl Med. 2004 Sep;18(6):519-26. doi: 10.1007/BF02984570.

    PMID: 15515753BACKGROUND

  • Johnson SA, Kumar A, Matasar MJ, Schoder H, Rademaker J. Imaging for Staging and Response Assessment in Lymphoma. Radiology. 2015 Aug;276(2):323-38. doi: 10.1148/radiol.2015142088.

    PMID: 26203705BACKGROUND

  • Chang DB, Yuan A, Yu CJ, Luh KT, Kuo SH, Yang PC. Differentiation of benign and malignant cervical lymph nodes with color Doppler sonography. AJR Am J Roentgenol. 1994 Apr;162(4):965-8. doi: 10.2214/ajr.162.4.8141027.

    PMID: 8141027BACKGROUND

  • Barrington SF, Mikhaeel NG, Kostakoglu L, Meignan M, Hutchings M, Mueller SP, Schwartz LH, Zucca E, Fisher RI, Trotman J, Hoekstra OS, Hicks RJ, O'Doherty MJ, Hustinx R, Biggi A, Cheson BD. Role of imaging in the staging and response assessment of lymphoma: consensus of the International Conference on Malignant Lymphomas Imaging Working Group. J Clin Oncol. 2014 Sep 20;32(27):3048-58. doi: 10.1200/JCO.2013.53.5229.

    PMID: 25113771BACKGROUND

Related Links

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • haisam ahmed samy, professor

    Assiut University

    STUDY DIRECTOR

  • mohamed moamen elbaroudy, doctor

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Hager mohammed abdelhafiez, master

CONTACT

01032690069solimanhager822@gmail.com

samy abdelaziz sayed, professor

CONTACT

0100 6788053samy5abdelaziz@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

February 11, 2022

First Posted

April 25, 2022

Study Start

June 1, 2022

Primary Completion

August 1, 2023

Study Completion

September 1, 2023

Last Updated

April 25, 2022

Record last verified: 2022-04