Dilemma on Pancreatic Uncinate Process Uptake on Ga68-DOTA Peptide PET/CT in Pediatric Neuroblastoma: Physiologic or Metastases?
Nedim C M Gulaldi, Nadide Basak Gulleroglu, Selma Cakmakci...
https://pubmed.ncbi.nlm.nih.gov/39966364Actively Recruiting
Age: 6Months +
All Genders
ID07195500
Clinical Application of Somatostatin Receptor and Norepinephrine Transporter Targeted Imaging for Diagnosis and Staging of Neuroblastoma and Pheochromocytoma/Paraganglioma
Led by Nanjing First Hospital, Nanjing Medical University · Updated on 2025-09-26
30
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of specialized molecular imaging techniques that target somatostatin receptors and norepinephrine transporters to diagnose and stage neuroblastoma and pheochromocytoma/paraganglioma in patients aged 6 months to 70 years. These methods include various radioactive tracers such as 18F-MFBG, 123I/131I-MIBG, and 68Ga-labeled peptides, aiming to determine their accuracy compared to the standard surgical pathology results. The study is observational and focuses on improving detection and treatment planning for these tumors. Participants will receive intravenous injections of selected tracers followed by PET/CT, PET/MRI, or SPECT/CT imaging, depending on the tracer used and patient suitability. The choice of tracer is personalized based on clinical factors, and some patients may undergo multiple tracer imaging within a short timeframe to allow direct comparison. Optional imaging with FDG and CXCR4-targeted agents may also be performed. The study includes standardized imaging acquisition, quantitative analysis, and comparison with histopathology and clinical follow-up as reference standards. During the study, participants will undergo initial assessments including medical history, physical exams, and lab tests. Imaging is performed at optimized times post-injection, followed by histopathological examination within two months. Safety is monitored for six months after imaging to track any adverse effects. Researchers will measure imaging parameters such as SUVmax and SUVmean, evaluate diagnostic accuracy and inter-reader agreement, and ensure radiation exposure stays within recommended levels. Data management follows strict quality and regulatory standards throughout the study duration, which extends up to one year on average per participant.
CONDITIONS
Brief Title
Clinical Application of Somatostatin Receptor and Norepinephrine Transporter Targeted Imaging for Diagnosis and Staging of Neuroblastoma and Pheochromocytoma/Paraganglioma
Who Can Participate
Age: 6Months +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 6 months or older (pediatric and adult).
- Suspected or confirmed neuroblastoma or pheochromocytoma/paraganglioma diagnosis.
- Clinical need for somatostatin receptor (SSTR) and/or norepinephrine transporter (NET) targeted molecular imaging for staging, restaging, recurrence suspicion, response assessment, or treatment planning.
- Ability to undergo PET/CT, PET/MRI, and/or SPECT/CT imaging as per protocol; no MRI contraindications for PET/MRI subset.
- Provision of written informed consent or assent as required.
- Women of childbearing potential must have a negative pregnancy test within 72 hours before tracer administration and agree to use effective contraception during imaging.
- Willingness to undergo two imaging studies within about 28 days without antitumor therapy for multi-tracer comparisons if applicable.
You will not qualify if you...
- Pregnant or breastfeeding participants unwilling or unable to follow lactation interruption guidance.
- Any condition preventing safe imaging or study compliance, such as uncontrolled heart or lung disease or severe claustrophobia not manageable by sedation.
- Known hypersensitivity to study radiopharmaceuticals or their components.
- Use of medications interfering with imaging tracers without feasible washout (e.g., labetalol, tricyclic antidepressants, certain sympathomimetics for NET imaging; recent somatostatin analogues for SSTR imaging).
- Prior therapeutic or high-dose 131I-MIBG within 6 months that could affect imaging.
- Contraindications to required imaging procedures (e.g., MRI-incompatible implants, contrast allergies if contrast is needed).
- Inability to remain still during imaging with no possibility of sedation.
- Concurrent participation in interventional studies or anticancer therapies that interfere with imaging interpretation within the imaging window; no systemic therapy between scans for multi-tracer comparisons.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Up to about 28 days for multi-tracer comparisons
Participants undergo somatostatin receptor (SSTR) and norepinephrine transporter (NET) targeted molecular imaging to detect and stage neuroblastoma or pheochromocytoma/paraganglioma. Imaging is performed using PET/CT, PET/MRI, and/or SPECT/CT with one or more radiotracers selected based on clinical indication and site availability.
1 to 2 imaging visits depending on tracer selection
Long-term Monitoring
Duration - Through study completion, approximately 1 year
Participants are observed through clinical follow-up and imaging for approximately 1 year to assess diagnostic accuracy, quantitative imaging metrics, and comparative performance between tracer classes.
Follow-up visits as clinically indicated
Trial Site Locations
Total: 1 location
1
Nanjing First Hospital
Nanjing, Jiangsu, China, 210000
Actively Recruiting
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Research Team
G
Guoqiang Shao, Dr
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Chia-Ju Liu, Kuan-Yin Ko, Meng-Yao Lu...
https://pubmed.ncbi.nlm.nih.gov/40512254Radiation Exposure to Patients and Others During Therapy for Pediatric Neuroblastoma With Lu-177-DOTATATE.
Zhaoqi Lu, Yanjinghui Sun, Di Zuo...
https://pubmed.ncbi.nlm.nih.gov/39992800MIBG in Neuroblastoma Diagnostic Imaging and Therapy.
Susan E Sharp, Andrew T Trout, Brian D Weiss...
https://pubmed.ncbi.nlm.nih.gov/26761540(123)I-mIBG scintigraphy in patients with known or suspected neuroblastoma: Results from a prospective multicenter trial.
Terry A Vik, Thomas Pfluger, Richard Kadota...
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Francesco Giammarile, Arturo Chiti, Michael Lassmann...
https://pubmed.ncbi.nlm.nih.gov/18274745Current concepts on the diagnostic use of MIBG in children.
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A Leung, B Shapiro, R Hattner...
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Emilio Bombardieri, Francesco Giammarile, Cumali Aktolun...
https://pubmed.ncbi.nlm.nih.gov/20644928123I-MIBG scintigraphy and 18F-FDG PET in neuroblastoma.
Susan E Sharp, Barry L Shulkin, Michael J Gelfand...
https://pubmed.ncbi.nlm.nih.gov/19617326