NCT06737835

Brief Summary

  1. 1.To assess staging accuracy of F-18 FDG PET/CT in lymphoma
  2. 2.Determine the role of F-18 FDG PET/CT in monitoring treatment response and detecting relapse or residual disease in lymphoma
  3. 3.To evaluate FDG uptake correlation with histopathological subtypes and immunophenotypes as a prognostic factor.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
13mo left

Started Jan 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress56%
Jan 2025Jun 2027

First Submitted

Initial submission to the registry

December 1, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 17, 2024

Completed
15 days until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

December 17, 2024

Status Verified

December 1, 2024

Enrollment Period

2 years

First QC Date

December 1, 2024

Last Update Submit

December 12, 2024

Conditions

Keywords

18 FDG PET CTLymphoma

Outcome Measures

Primary Outcomes (1)

  • primary

    Treatment Response Using Deauville Score for FDG Uptake Evaluation: Evaluate FDG uptake using the 5-point scale: 1. No uptake above background 2. Uptake ≤ mediastinum 3. Uptake \> mediastinum but ≤ liver 4. Moderately increased compared to liver 5. Markedly increased compared to liver X: New uptake, unlikely related to lymphoma

    3 years

Secondary Outcomes (1)

  • secondary

    3 years

Interventions

18 FDGDEVICE

18 flurodeoxy glucose PET/CT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This is a prospective study data collected from a single-center Clinical Oncology and Nuclear Medicine Department - Assuit University Hospital, which included 62 lymphoma cases who underwent F-18 FDG PET/CT for disease staging, treatment response assessment, or post-treatment monitoring.

You may qualify if:

  • Age: Patient must be older than 18 years.
  • Confirmed Diagnosis of Lymphoma: Patient must have a confirmed diagnosis of lymphoma based on histopathology and immunophenotyping.

You may not qualify if:

  • Patients with Known concomitant malignancy.
  • Pregnancy: Pregnant women due to the potential risks associated with radiation exposure from the PET/CT scan.
  • Severe Renal or Hepatic Impairment: Patients with significant renal or hepatic dysfunction that could affect FDG metabolism or excretion.
  • Uncontrolled Diabetes: Patients with uncontrolled diabetes (blood glucose \>200 mg/dL), as it can affect FDG uptake and PET/CT results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nuclear medicine- Assiut University Hospital

Asyut, Egypt

Location

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Esraa R Hassan, MD

    South Egypt Cancer Institute

    STUDY DIRECTOR

Central Study Contacts

Aya A Ahmed Ali ALsanory, MSc

CONTACT

Mohamed A Mekkawy, Prof

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant lecturer

Study Record Dates

First Submitted

December 1, 2024

First Posted

December 17, 2024

Study Start

January 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

December 17, 2024

Record last verified: 2024-12

Locations