Pitfalls of PET Scan on PediatticNCT06612567
Normal Variants and Pitfalls of 18F_FDG PET/CT in Pediatric Oncology
An observational study of Pitfalls of PET Scan on Pediattic, run by Assiut University.
Trial summary
Detection Normal variants and pitfalls of 18_F _FDG PET/CT imaging in pediatic oncology. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Pitfalls of PET Scan on Pediattic
- What is being tested?
- PET/CT
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients that will underwent PET/CT scan
Who may be able to join
- All Pediatric Cancer patients referred to nuclear medicine unit to do 18F-FDG PET/CT study.
- All patients \> or = 18 years.
Who cannot join
- Severely ill patients. Patients with glucose level \< 200 mg/dl.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Normal Variants and Pitfalls of 18F_FDG PET/CT Imaging in Pediatric Oncology
Detection Normal variants and pitfalls of 18_F _FDG PET/CT imaging in pediatic oncology.
Read the detailed description
Although pediatric cancer is relatively rare compared with adult cancer, it is the second most common cause of death, after injury in children and adolescents. lymphoma, Leukemia, and brain cancer, account for more than half of pediatric cancers, followed by neuroblastoma, soft-tissue sarcomas, Wilms tumors, and bone tumors .
18Fluorine-fluorodeoxyglucose (18F-FDG) positron emission tomography/computed tomography (PET/CT) plays an important role, staging, restaging, response to treatment in childhood malignancies. PET-only examinations have been replaced by hybrid systems in the recent decades, where PET and CT are used together in oncology. In this imaging system, PET and CT are used together for functional data and morphological information, respectively. (2) Although 18F-FDG PET/CT is now well established as an accurate method for the staging and restaging of various cancers, it is also well recognized that many false-positive results can occur .
The normal distribution of FDG uptake in children differs from adults. Also, even though FDG is used widely in oncology, it is not tumor specific. Uptake of FDG may be seen in numerous benign conditions, including inflammation, infection, and trauma. Proper interpretation of pediatric FDG PET/CT studies requires knowledge of the normal distribution of FDG uptake in children, and an insight into the physiologic variants, benign lesions, and PET/CT related artifacts.
By understanding the potential causes of misinterpretation, we can increase the accuracy of interpretation, decrease the number of unnecessary follow-up studies and improve treatment outcome.
- Conditions
- Pitfalls of PET Scan on Pediattic
- Being tested
- PET/CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CTDiagnostic test
is an imaging test that can help reveal the metabolic or biochemical function of your tissues and organs. The PET scan uses a radioactive drug called a tracer to show both typical and atypical metabolic activity. A PET scan can often detect the atypical metabolism of the tracer in diseases before the disease shows up on other imaging tests, such as computerized tomography (CT) and magnetic resonance imaging (MRI).
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection normal variants and pitfalls of 18F-FDG PET/CT Imaging in Pediatric oncology that interfere in PET/CT study results and interpretation.
Detection normal variants and pitfalls of 18F-FDG PET/CT Imaging in Pediatric oncology that interfere in PET/CT study results and interpretation by follow up with PET/CT or other imagining or clinically
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study startOct 2024 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pitfalls of PET Scan on PediatticStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Atef Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06612567
- Sponsor's protocol ID
- Pitfalls PET/CT In pediatric
- Status last verified
- Sep 2024
- First submitted
- 22 Sep 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
https://doi.org/10.3389/fnume.2022.825891
Smith CS, Schoder H, Yeung HW. Thymic extension in the superior mediastinum in patients with thymic hyperplasia: potential cause of false-positive findings on 18F-FDG PET/CT. AJR Am J Roentgenol. 2007 Jun;188(6):1716-21. doi: 10.2214/AJR.06.0552.
PubMed 17515398Bicakci N, Elli M. 18Fluorine-fluorodeoxyglucose PET/CT Imaging in Childhood Malignancies. Mol Imaging Radionucl Ther. 2021 Feb 9;30(1):18-27. doi: 10.4274/mirt.galenos.2020.64436.
PubMed 33586403Vali R, Alessio A, Balza R, Borgwardt L, Bar-Sever Z, Czachowski M, Jehanno N, Kurch L, Pandit-Taskar N, Parisi M, Piccardo A, Seghers V, Shulkin BL, Zucchetta P, Lim R. SNMMI Procedure Standard/EANM Practice Guideline on Pediatric 18F-FDG PET/CT for Oncology 1.0. J Nucl Med. 2021 Jan;62(1):99-110. doi: 10.2967/jnumed.120.254110.
PubMed 33334912
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normal Variants and Pitfalls of 18F_FDG PET/CT Imaging in Pediatric Oncology
- ClinicalTrials.gov ID
- NCT06612567
- Acronym / sponsor ID
- Pitfalls PET/CT In pediatric
- Conditions
- Pitfalls of PET Scan on Pediattic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 25 Sep 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.
Detection Normal variants and pitfalls of 18_F _FDG PET/CT imaging in pediatic oncology.
Detailed description
Although pediatric cancer is relatively rare compared with adult cancer, it is the second most common cause of death, after injury in children and adolescents. lymphoma, Leukemia, and brain cancer, account for more than half of pediatric cancers, followed by neuroblastoma, soft-tissue sarcomas, Wilms tumors, and bone tumors .
18Fluorine-fluorodeoxyglucose (18F-FDG) positron emission tomography/computed tomography (PET/CT) plays an important role, staging, restaging, response to treatment in childhood malignancies. PET-only examinations have been replaced by hybrid systems in the recent decades, where PET and CT are used together in oncology. In this imaging system, PET and CT are used together for functional data and morphological information, respectively. (2) Although 18F-FDG PET/CT is now well established as an accurate method for the staging and restaging of various cancers, it is also well recognized that many false-positive results can occur .
The normal distribution of FDG uptake in children differs from adults. Also, even though FDG is used widely in oncology, it is not tumor specific. Uptake of FDG may be seen in numerous benign conditions, including inflammation, infection, and trauma. Proper interpretation of pediatric FDG PET/CT studies requires knowledge of the normal distribution of FDG uptake in children, and an insight into the physiologic variants, benign lesions, and PET/CT related artifacts.
By understanding the potential causes of misinterpretation, we can increase the accuracy of interpretation, decrease the number of unnecessary follow-up studies and improve treatment outcome.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients that will underwent PET/CT scan
Key inclusion criteria (2 listed)
- All Pediatric Cancer patients referred to nuclear medicine unit to do 18F-FDG PET/CT study.
- All patients \> or = 18 years.
Key exclusion criteria (1 listed)
- Severely ill patients. Patients with glucose level \< 200 mg/dl.
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 |
|---|---|---|
| PET/CTis an imaging test that can help reveal the metabolic or biochemical function of your tissues and organs. The PET scan uses a radioactive drug called a tracer to show both typical and atypical metabolic activity. A PET scan can often detect the atypical metabolism of the tracer in diseases before the disease shows up on other imaging tests, such as computerized tomography (CT) and magnetic resonance imaging (MRI). | Diagnostic test | – |
Primary outcome
Detection normal variants and pitfalls of 18F-FDG PET/CT Imaging in Pediatric oncology that interfere in PET/CT study results and interpretation.
Time frame: Baseline
Detection normal variants and pitfalls of 18F-FDG PET/CT Imaging in Pediatric oncology that interfere in PET/CT study results and interpretation by follow up with PET/CT or other imagining or clinically
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Backgroundhttps://doi.org/10.3389/fnume.2022.825891
- Background: PubMed 17515398Smith CS, Schoder H, Yeung HW. Thymic extension in the superior mediastinum in patients with thymic hyperplasia: potential cause of false-positive findings on 18F-FDG PET/CT. AJR Am J Roentgenol. 2007 Jun;188(6):1716-21. doi: 10.2214/AJR.06.0552.
- Background: PubMed 33586403Bicakci N, Elli M. 18Fluorine-fluorodeoxyglucose PET/CT Imaging in Childhood Malignancies. Mol Imaging Radionucl Ther. 2021 Feb 9;30(1):18-27. doi: 10.4274/mirt.galenos.2020.64436.
- Background: PubMed 33334912Vali R, Alessio A, Balza R, Borgwardt L, Bar-Sever Z, Czachowski M, Jehanno N, Kurch L, Pandit-Taskar N, Parisi M, Piccardo A, Seghers V, Shulkin BL, Zucchetta P, Lim R. SNMMI Procedure Standard/EANM Practice Guideline on Pediatric 18F-FDG PET/CT for Oncology 1.0. J Nucl Med. 2021 Jan;62(1):99-110. doi: 10.2967/jnumed.120.254110.
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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Pitfalls of PET Scan on Pediattic, run by Assiut University.
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 1 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: status not confirmed, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amira Atef Mohamed, Resident doctor (+20 1017064445, ameraatef781@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection normal variants and pitfalls of 18F-FDG PET/CT Imaging in Pediatric oncology that interfere in PET/CT study results and interpretation. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06612567, which also lists 4 linked publications.
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 25 Sep 2024.