Phase I trial of 90Y-DOTATOC therapy in children and young adults with refractory solid tumors that express somatostatin receptors.
Yusuf Menda, M Sue O'Dorisio, Simon Kao...
https://pubmed.ncbi.nlm.nih.gov/20847174Actively Recruiting
Age: 0 - 18Years
All Genders
ID07064746
Clinical Application Study of [123I]Metaiodobenzylguanidine and Somatostatin Receptor-Targeted Imaging in the Diagnosis and Staging of Neuroblastoma
Led by Nanjing First Hospital, Nanjing Medical University · Updated on 2025-07-21
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
N
Nanjing First Hospital, Nanjing Medical University
Lead Sponsor
J
Jiangsu Province Hospital of Traditional Chinese Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to assess the diagnostic accuracy of two imaging methods, 123I-MIBG SPECT/CT and somatostatin receptor (SSTR) PET, in Chinese children suspected or confirmed to have neuroblastoma (NB). It focuses on determining the sensitivity and specificity of each imaging technique alone and combined for initial cancer staging and detecting relapses or metastases. The study also explores whether SSTR-targeted PET can identify NB lesions that do not absorb MIBG and help select candidates for peptide-receptor radionuclide therapy (PRRT). The study includes pediatric patients up to 18 years old undergoing routine NB evaluation. They will receive both 123I-MIBG SPECT/CT and SSTR PET/CT or PET/MRI imaging. For 123I-MIBG, patients receive thyroid protection with Lugol's iodine and an intravenous radioactive tracer, followed by whole-body and focused imaging. The SSTR PET involves intravenous injection of 68Ga-DOTA-TATE followed by whole-body PET/CT or PET/MRI scanning. Sedation is used as needed for motion control during imaging. Participants will be monitored through clinical follow-up and imaging results correlated with pathology and clinical course over 24 months. Researchers will measure standardized uptake values (SUVmean, SUVmax, SUVpeak) at baseline and six months to evaluate tumor activity. The study aims to provide detailed imaging insights for better NB diagnosis, staging, treatment planning, and response evaluation in Chinese children.
CONDITIONS
Brief Title
Clinical Application Study of [123I]Metaiodobenzylguanidine and Somatostatin Receptor-Targeted Imaging in the Diagnosis and Staging of Neuroblastoma
Who Can Participate
Age: 0 - 18Years
All Genders
Eligibility Criteria
You may qualify if you...
- Ages 0 to 18 years, any sex
- Histologically confirmed or clinically highly suspected neuroblastoma with planned imaging assessment
- At least one measurable lesion on conventional imaging such as CT or MRI
- ECOG performance status 0-2 and expected survival of 3 months or more
- Adequate blood counts and liver/kidney function (Hb ≥ 90 g/L, ANC ≥ 1.5 × 10⁹/L, platelets ≥ 100 × 10⁹/L, ALT/AST ≤ 2.5 × ULN, creatinine ≤ 1.5 × ULN)
- Informed consent signed by participant or legal guardian
You will not qualify if you...
- Severe allergy to radioactive isotopes or imaging agent components
- Pregnancy or breastfeeding
- Receipt of high-dose chemotherapy, radiotherapy, radionuclide therapy, or participation in other interventional trials within past 4 weeks
- Severe or uncontrolled heart, lung, liver, or kidney failure; active severe infection
- Bone marrow suppression not recovered (Hb < 90 g/L, ANC < 1.5 × 10⁹/L, platelets < 100 × 10⁹/L)
- Inability to complete imaging exams (e.g., severe claustrophobia, unable to lie still for 30 minutes or more)
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
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 - Single day for imaging procedures
Participants undergo diagnostic imaging with ¹²³I-MIBG SPECT/CT and SSTR PET/CT to detect, stage, and plan treatment for neuroblastoma.
1 to 2 imaging visits depending on required scans
Long-term Monitoring
Duration - Up to 6 months
Participants have follow-up imaging assessments to monitor disease status and response to therapy over time.
Follow-up imaging visits at baseline and 6 months
Trial Site Locations
Total: 1 location
1
Nanjing First Hospital
Nanjing, Jiangsu, China, 210000
Actively Recruiting
Loading map...
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Prospective Study of 68Ga-DOTATATE Positron Emission Tomography/Computed Tomography for Detecting Gastro-Entero-Pancreatic Neuroendocrine Tumors and Unknown Primary Sites.
Samira M Sadowski, Vladimir Neychev, Corina Millo...
https://pubmed.ncbi.nlm.nih.gov/26712231177Lu-DOTATATE molecular radiotherapy for childhood neuroblastoma.
Jennifer E Gains, Jamshed B Bomanji, Naomi L Fersht...
https://pubmed.ncbi.nlm.nih.gov/21680680Initial Experience With Gallium-68 DOTA-Octreotate PET/CT and Peptide Receptor Radionuclide Therapy for Pediatric Patients With Refractory Metastatic Neuroblastoma.
Grace Kong, Michael S Hofman, William K Murray...
https://pubmed.ncbi.nlm.nih.gov/26296147Somatostatin receptor imaging with 68Ga DOTATATE PET/CT: clinical utility, normal patterns, pearls, and pitfalls in interpretation.
Michael S Hofman, W F Eddie Lau, Rodney J Hicks
https://pubmed.ncbi.nlm.nih.gov/25763733Differentiated expression of somatostatin receptor subtypes in experimental models and clinical neuroblastoma.
Kleopatra Georgantzi, Apostolos V Tsolakis, Mats Stridsberg...
https://pubmed.ncbi.nlm.nih.gov/21298743Expression of somatostatin receptors in childhood neuroblastoma.
C L Moertel, J C Reubi, B S Scheithauer...
https://pubmed.ncbi.nlm.nih.gov/7801887Somatostatin receptor gene expression in neuroblastoma.
A R Albers, M S O'Dorisio, D A Balster...
https://pubmed.ncbi.nlm.nih.gov/10706954Characterization of somatostatin receptors on human neuroblastoma tumors.
M S O'Dorisio, F Chen, T M O'Dorisio...
https://pubmed.ncbi.nlm.nih.gov/8123588Measurement of somatostatin receptor subtype 2 mRNA in breast cancer and corresponding normal tissue.
C Orlando, C Casini Raggi, S Bianchi...
https://pubmed.ncbi.nlm.nih.gov/15163307