LymphomaNCT06737835
Metabolic Insights: the Impact of F-18 FDG PET/CT in Adult Lymphoma
An observational study of Lymphoma, run by Assiut University at 1 site in Egypt.
Trial summary
1. To assess staging accuracy of F-18 FDG PET/CT in lymphoma 2. Determine the role of F-18 FDG PET/CT in monitoring treatment response and detecting relapse or residual disease in lymphoma 3. To evaluate FDG uptake correlation with histopathological subtypes and immunophenotypes as a prognostic factor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- 18 FDG
- Type of treatment
- Medical device
- How many people
- 62 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 1 Jun 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Nuclear medicine- Assiut University Hospital
Asyut
Aya A Al-sanoory, MSC, 00201063490867, ayota17@gmail.com
About this study
- To assess staging accuracy of F-18 FDG PET/CT in lymphoma
- Determine the role of F-18 FDG PET/CT in monitoring treatment response and detecting relapse or residual disease in lymphoma
- To evaluate FDG uptake correlation with histopathological subtypes and immunophenotypes as a prognostic factor.
Read the detailed description
The incidence of lymphoma in Egypt has been increasing in recent years, with a noticeable rise in both Hodgkin's and non-Hodgkin's lymphoma cases. This increase is due to better healthcare, awareness, and diagnostic advancements. Risk factors include infections, lifestyle, genetics, and immune system issues.
Lymphoma is now the fourth most prevalent cancer among Egyptian adults, accounting for approximately 8.4% of all new cancer cases annually. As the burden of lymphoma grows, it becomes essential to develop effective strategies for its diagnosis and management.
Flurodeoxyglucose F-18 (F-18 FDG) is a radiolabeled glucose analog that accumulates in metabolically active cells, such as lymphoma cells, making F-18 FDG positron emission tomography / computed tomography scan (PET/CT) highly sensitive for detecting malignant lesions. It plays a key role in staging lymphoma by assessing the extent of disease spread.
Additionally, F-18 FDG PET/CT is essential for assessing treatment response, detecting relapses early, and evaluating the prognosis of patients, offering prognostic value by evaluating residual disease and predicting recurrence. Its ability to monitor disease progression and detect recurrent lymphoma provides critical insights that guide therapeutic decisions and long-term outcomes.
- Conditions
- Lymphoma
- Being tested
- 18 FDG
- Keywords
- 18 FDG PET CT, Lymphoma
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18 FDGDevice
18 flurodeoxy glucose PET/CT
What is being measured
The primary outcome is the main question the study is designed to answer.
primary
Treatment Response Using Deauville Score for FDG Uptake Evaluation:
Evaluate FDG uptake using the 5-point scale:
- No uptake above background
- Uptake ≤ mediastinum
- Uptake > mediastinum but ≤ liver
- Moderately increased compared to liver
- Markedly increased compared to liver X: New uptake, unlikely related to lymphoma
Measured: 3 years
Secondary outcomes (1)
secondary
Detect early relapse or residual disease using F-18 FDG PET/CT using SUVmax, maximum standardized uptake value(g/mL )
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Abdel-Baset Ahmed Ali Alsanory, Assiut University
- Investigators
- Esraa R Hassan, MD, Study director, South Egypt Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06737835
- Sponsor's protocol ID
- PET/CT in adult lymphoma
- Status last verified
- Dec 2024
- First submitted
- 1 Dec 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Insights: the Impact of F-18 FDG PET/CT in Adult Lymphoma
- ClinicalTrials.gov ID
- NCT06737835
- Acronym / sponsor ID
- PET/CT in adult lymphoma
- Conditions
- Lymphoma
- Keywords
- 18 FDG PET CT, Lymphoma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 17 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To assess staging accuracy of F-18 FDG PET/CT in lymphoma
- Determine the role of F-18 FDG PET/CT in monitoring treatment response and detecting relapse or residual disease in lymphoma
- To evaluate FDG uptake correlation with histopathological subtypes and immunophenotypes as a prognostic factor.
Detailed description
The incidence of lymphoma in Egypt has been increasing in recent years, with a noticeable rise in both Hodgkin's and non-Hodgkin's lymphoma cases. This increase is due to better healthcare, awareness, and diagnostic advancements. Risk factors include infections, lifestyle, genetics, and immune system issues.
Lymphoma is now the fourth most prevalent cancer among Egyptian adults, accounting for approximately 8.4% of all new cancer cases annually. As the burden of lymphoma grows, it becomes essential to develop effective strategies for its diagnosis and management.
Flurodeoxyglucose F-18 (F-18 FDG) is a radiolabeled glucose analog that accumulates in metabolically active cells, such as lymphoma cells, making F-18 FDG positron emission tomography / computed tomography scan (PET/CT) highly sensitive for detecting malignant lesions. It plays a key role in staging lymphoma by assessing the extent of disease spread.
Additionally, F-18 FDG PET/CT is essential for assessing treatment response, detecting relapses early, and evaluating the prognosis of patients, offering prognostic value by evaluating residual disease and predicting recurrence. Its ability to monitor disease progression and detect recurrent lymphoma provides critical insights that guide therapeutic decisions and long-term outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18 FDG18 flurodeoxy glucose PET/CT | Device | – |
Primary outcome
primary
Time frame: 3 years
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
1 secondary outcome
secondary
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Esraa R Hassan, MD study director
South Egypt Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aya A Ahmed Ali ALsanory, MSc (00201063490867, ayota17@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.