Clinical Application Study of [123I]Metaiodobenzylguanidine and Somatostatin Receptor-Targeted Imaging in the Diagnosis and Staging of Neuroblastoma
NCT ID: NCT07064746
Last Updated: 2025-07-21
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Total Enrollment
150 participants
Study Classification
OBSERVATIONAL
Study Start Date
2022-07-10
Study Completion Date
2027-07-10
Brief Summary
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The goal of this prospective observational study is to evaluate the diagnostic performance of ¹²³I-MIBG SPECT/CT and SSTR PET in Chinese children with suspected or confirmed neuroblastoma (NB). The main questions it aims to answer are:
* What are the sensitivity and specificity of each modality-alone and combined-for initial staging and for detecting relapse or metastasis?
* Can SSTR-targeted PET reliably identify MIBG-negative NB lesions and help select candidates for peptide-receptor radionuclide therapy (PRRT)?
Pediatric patients (≤18 years) undergoing routine evaluation for NB will receive both imaging studies; results will be correlated with histopathology, clinical course, and 24-month follow-up.
* What are the sensitivity and specificity of each modality-alone and combined-for initial staging and for detecting relapse or metastasis?
* Can SSTR-targeted PET reliably identify MIBG-negative NB lesions and help select candidates for peptide-receptor radionuclide therapy (PRRT)?
Pediatric patients (≤18 years) undergoing routine evaluation for NB will receive both imaging studies; results will be correlated with histopathology, clinical course, and 24-month follow-up.
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Detailed Description
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Neuroblastoma (NB) is the most common extracranial solid tumor in children. More than 50 % of cases occur before the age of two, while diagnoses after 10 years old are rare. NB accounts for approximately 6 - 10 % of pediatric malignancies. Its biological behavior is highly heterogeneous, with diverse molecular features, a high risk of metastasis, and often occult primary sites, making early detection and definitive diagnosis difficult \[1-3\]. Rapid disease progression further complicates treatment.
In recent years, driven by large international multicenter collaborations, the diagnosis and management of pediatric NB have entered an era of molecular imaging and targeted theranostics. Especially overseas, rapid advances in screening, diagnosis, treatment research, and clinical translation have yielded well-established guidelines and consensus statements, markedly improving the 5-year survival rate \[4\]. In contrast, research and clinical translation in China lag behind, and understanding of NB biology varies across regions, leading to uneven diagnostic and therapeutic levels without unified protocols. As a result, an increasing number of Chinese patients seek molecular imaging and targeted therapy abroad. Accelerating domestic translation of new NB technologies is thus critical to improving outcomes.
Nuclear medicine imaging (molecular imaging) employs radionuclide-labeled tracers for early lesion detection. For NB, modalities include classic radioiodinated metaiodobenzylguanidine (MIBG) imaging (¹³¹I/¹²³I/¹²⁴I-MIBG, ¹⁸F-MFBG), ¹⁸F-FDG metabolic imaging, somatostatin-receptor (SSTR)-targeted imaging (⁶⁸Ga-DOTA-TATE/TOC/NOC peptides), and ¹⁸F-DOPA imaging. With continual upgrades of SPECT/CT, quantitative SPECT/CT, and PET/CT-MRI, comparative studies on diagnostic accuracy, staging, early detection of relapse/metastasis, radiation safety, and therapy response assessment have flourished. International indications for NB radionuclide imaging include \[5-7\]: confirmation of suspected NB/pheochromocytoma/ganglioneuroma, disease staging, treatment planning and response evaluation, post-therapy follow-up, and selection for radionuclide therapy.
NB cells overexpress the norepinephrine transporter; hence norepinephrine analogs such as MIBG are ideal imaging (and therapeutic) ligands. Radioiodinated MIBG accumulates in neural-crest-derived tissues and tumors, exhibiting high sensitivity (88-92 %) and specificity (83-92 %) \[8\]. It distinguishes residual tumor from non-specific findings on anatomic imaging and more accurately evaluates bone marrow metastases than MRI \[10, 11\]. ¹³¹I-MIBG is widely used therapeutically, and post-therapy ¹³¹I-MIBG scans assess tracer uptake, disease status, and predict response, forming part of theranostic guidelines \[8, 9, 12-14\]. However, ¹³¹I emits high-energy γ-photons (364 keV) and has a long half-life, resulting in poorer SPECT image quality and lower sensitivity than ¹²³I (159 keV, much shorter half-life). The shorter half-life of ¹²³I permits higher administered activity within the same radiation dose, yielding superior images \[15\]. Consequently, ¹²³I-MIBG is expected to become the optimal screening tool for selecting patients for ¹³¹I-MIBG therapy. In high-risk NB, ¹²³I-MIBG detects recurrent bone metastases in 94 % of cases versus 43 % for ¹⁸F-FDG PET/CT \[9, 10\]. MIBG imaging remains the standard for staging and treatment assessment \[16-18\].
About 10 % of NBs show low or absent MIBG uptake, risking false-negative results. Combining modalities helps overcome this limitation. Somatostatin, a hypothalamic peptide that inhibits pituitary growth hormone and gastrointestinal hormones \[19-21\], binds receptors found on pancreatic, neuroendocrine, meningeal, and breast tumors \[21-24\]. High-affinity SSTRs are expressed in 77-89 % of NB cells \[25-28\]. Numerous ⁶⁸Ga-DOTA peptides target SSTRs, such as ⁶⁸Ga-DOTA-TATE (highest affinity for SSTR2), ⁶⁸Ga-DOTA-TOC (SSTR5), and ⁶⁸Ga-DOTA-NOC (SSTR3 and SSTR5) \[29\]. Compared with ¹²³/¹³¹I-MIBG, SSTR-PET/CT offers advantages: faster plasma clearance (2 h vs 2 days), same-day injection and imaging, shorter ⁶⁸Ga half-life (68 min vs 13.1 h/8 days), rapid acquisition (20-40 min vs \~1 h), and minimal preparation (no Lugol's solution). One study showed ⁶⁸Ga-DOTA-TOC PET/CT sensitivity of 94.4 %, significantly higher than ¹²³I-MIBG (76.9 %).
Systematic data on MIBG and SSTR imaging in Chinese NB are scarce. Peptide receptor radionuclide therapy (PRRT) with agents like ¹⁷⁷Lu-DOTA-TATE-proven feasible and safe abroad \[30, 31\]-is attractive, offering outpatient treatment without thyroid blockade, simplifying care for children and families. Small studies have applied PRRT to relapsed pediatric NB \[32-35\].
Given tumor heterogeneity, different molecular probes deliver complementary diagnostic and therapeutic information. Although combination imaging is well studied internationally, domestic data are lacking. Ethnic and regional factors warrant investigation. This study will employ ¹²³I-MIBG SPECT/CT fusion and SSTR PET/CT or(and) MRI for NB diagnosis, staging, and follow-up, aiming to provide valuable insights for early definitive diagnosis, precise staging, radionuclide-targeted therapy, and response evaluation in Chinese patients. In heterogeneous tumors, multimodal imaging is expected to offer clear advantages for staging, phenotype characterization, prognostication, and treatment planning.
In recent years, driven by large international multicenter collaborations, the diagnosis and management of pediatric NB have entered an era of molecular imaging and targeted theranostics. Especially overseas, rapid advances in screening, diagnosis, treatment research, and clinical translation have yielded well-established guidelines and consensus statements, markedly improving the 5-year survival rate \[4\]. In contrast, research and clinical translation in China lag behind, and understanding of NB biology varies across regions, leading to uneven diagnostic and therapeutic levels without unified protocols. As a result, an increasing number of Chinese patients seek molecular imaging and targeted therapy abroad. Accelerating domestic translation of new NB technologies is thus critical to improving outcomes.
Nuclear medicine imaging (molecular imaging) employs radionuclide-labeled tracers for early lesion detection. For NB, modalities include classic radioiodinated metaiodobenzylguanidine (MIBG) imaging (¹³¹I/¹²³I/¹²⁴I-MIBG, ¹⁸F-MFBG), ¹⁸F-FDG metabolic imaging, somatostatin-receptor (SSTR)-targeted imaging (⁶⁸Ga-DOTA-TATE/TOC/NOC peptides), and ¹⁸F-DOPA imaging. With continual upgrades of SPECT/CT, quantitative SPECT/CT, and PET/CT-MRI, comparative studies on diagnostic accuracy, staging, early detection of relapse/metastasis, radiation safety, and therapy response assessment have flourished. International indications for NB radionuclide imaging include \[5-7\]: confirmation of suspected NB/pheochromocytoma/ganglioneuroma, disease staging, treatment planning and response evaluation, post-therapy follow-up, and selection for radionuclide therapy.
NB cells overexpress the norepinephrine transporter; hence norepinephrine analogs such as MIBG are ideal imaging (and therapeutic) ligands. Radioiodinated MIBG accumulates in neural-crest-derived tissues and tumors, exhibiting high sensitivity (88-92 %) and specificity (83-92 %) \[8\]. It distinguishes residual tumor from non-specific findings on anatomic imaging and more accurately evaluates bone marrow metastases than MRI \[10, 11\]. ¹³¹I-MIBG is widely used therapeutically, and post-therapy ¹³¹I-MIBG scans assess tracer uptake, disease status, and predict response, forming part of theranostic guidelines \[8, 9, 12-14\]. However, ¹³¹I emits high-energy γ-photons (364 keV) and has a long half-life, resulting in poorer SPECT image quality and lower sensitivity than ¹²³I (159 keV, much shorter half-life). The shorter half-life of ¹²³I permits higher administered activity within the same radiation dose, yielding superior images \[15\]. Consequently, ¹²³I-MIBG is expected to become the optimal screening tool for selecting patients for ¹³¹I-MIBG therapy. In high-risk NB, ¹²³I-MIBG detects recurrent bone metastases in 94 % of cases versus 43 % for ¹⁸F-FDG PET/CT \[9, 10\]. MIBG imaging remains the standard for staging and treatment assessment \[16-18\].
About 10 % of NBs show low or absent MIBG uptake, risking false-negative results. Combining modalities helps overcome this limitation. Somatostatin, a hypothalamic peptide that inhibits pituitary growth hormone and gastrointestinal hormones \[19-21\], binds receptors found on pancreatic, neuroendocrine, meningeal, and breast tumors \[21-24\]. High-affinity SSTRs are expressed in 77-89 % of NB cells \[25-28\]. Numerous ⁶⁸Ga-DOTA peptides target SSTRs, such as ⁶⁸Ga-DOTA-TATE (highest affinity for SSTR2), ⁶⁸Ga-DOTA-TOC (SSTR5), and ⁶⁸Ga-DOTA-NOC (SSTR3 and SSTR5) \[29\]. Compared with ¹²³/¹³¹I-MIBG, SSTR-PET/CT offers advantages: faster plasma clearance (2 h vs 2 days), same-day injection and imaging, shorter ⁶⁸Ga half-life (68 min vs 13.1 h/8 days), rapid acquisition (20-40 min vs \~1 h), and minimal preparation (no Lugol's solution). One study showed ⁶⁸Ga-DOTA-TOC PET/CT sensitivity of 94.4 %, significantly higher than ¹²³I-MIBG (76.9 %).
Systematic data on MIBG and SSTR imaging in Chinese NB are scarce. Peptide receptor radionuclide therapy (PRRT) with agents like ¹⁷⁷Lu-DOTA-TATE-proven feasible and safe abroad \[30, 31\]-is attractive, offering outpatient treatment without thyroid blockade, simplifying care for children and families. Small studies have applied PRRT to relapsed pediatric NB \[32-35\].
Given tumor heterogeneity, different molecular probes deliver complementary diagnostic and therapeutic information. Although combination imaging is well studied internationally, domestic data are lacking. Ethnic and regional factors warrant investigation. This study will employ ¹²³I-MIBG SPECT/CT fusion and SSTR PET/CT or(and) MRI for NB diagnosis, staging, and follow-up, aiming to provide valuable insights for early definitive diagnosis, precise staging, radionuclide-targeted therapy, and response evaluation in Chinese patients. In heterogeneous tumors, multimodal imaging is expected to offer clear advantages for staging, phenotype characterization, prognostication, and treatment planning.
Conditions
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Neuroblastoma (NB)
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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Pediatric Neuroblastoma Imaging Cohort
This cohort includes pediatric patients (≤18 years) with suspected or confirmed neuroblastoma. Interventions include diagnostic imaging with ¹²³I-MIBG SPECT/CT and SSTR PET/CT for staging, therapy planning, and disease monitoring.
¹²³I-MIBG SPECT/CT
Intervention Type
DIAGNOSTIC_TEST
Patients take Lugol's iodine 2 days and on the day of injection for thyroid blockade. ¹²³I-MIBG (3-5 MBq/kg; max 370 MBq) is given IV. Whole-body planar imaging is performed 24 h post-injection, then focused SPECT/CT of any suspicious areas with low-dose CT; children are sedated only if motion control is required.
SSTR PET
Intervention Type
DIAGNOSTIC_TEST
Patients receive an intravenous bolus of 68Ga-DOTA-TATE (1.8-2.2 MBq/kg, max 200 MBq). After a 45-60 min uptake phase, a low-dose whole-body PET/CT or PET/MRI (skull base-mid-thigh) is acquired for \~20 min; MRI or CT provides attenuation correction. Sedation used when required.
Interventions
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¹²³I-MIBG SPECT/CT
Patients take Lugol's iodine 2 days and on the day of injection for thyroid blockade. ¹²³I-MIBG (3-5 MBq/kg; max 370 MBq) is given IV. Whole-body planar imaging is performed 24 h post-injection, then focused SPECT/CT of any suspicious areas with low-dose CT; children are sedated only if motion control is required.
Intervention Type
DIAGNOSTIC_TEST
SSTR PET
Patients receive an intravenous bolus of 68Ga-DOTA-TATE (1.8-2.2 MBq/kg, max 200 MBq). After a 45-60 min uptake phase, a low-dose whole-body PET/CT or PET/MRI (skull base-mid-thigh) is acquired for \~20 min; MRI or CT provides attenuation correction. Sedation used when required.
Intervention Type
DIAGNOSTIC_TEST
Eligibility Criteria
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Inclusion Criteria
1. Ages 0-18 years, any sex
2. Histologically confirmed or clinically highly suspected neuroblastoma with planned imaging assessment
3. At least one measurable lesion on conventional imaging such as CT or MRI
4. ECOG performance status 0-2 and an expected survival of ≥3 months
5. Hematologic, hepatic, and renal function meeting the following criteria: Hb ≥ 90 g/L, ANC ≥ 1.5 × 10⁹/L, platelets ≥ 100 × 10⁹/L, ALT/AST ≤ 2.5 × ULN, Cr ≤ 1.5 × ULN
6. Informed consent signed by the subject or legal guardian
2. Histologically confirmed or clinically highly suspected neuroblastoma with planned imaging assessment
3. At least one measurable lesion on conventional imaging such as CT or MRI
4. ECOG performance status 0-2 and an expected survival of ≥3 months
5. Hematologic, hepatic, and renal function meeting the following criteria: Hb ≥ 90 g/L, ANC ≥ 1.5 × 10⁹/L, platelets ≥ 100 × 10⁹/L, ALT/AST ≤ 2.5 × ULN, Cr ≤ 1.5 × ULN
6. Informed consent signed by the subject or legal guardian
Exclusion Criteria
1. Known history of severe allergy to the radioactive isotope or molecular probe components to be used;
2. Pregnancy or lactation;
3. Receipt of high-dose chemotherapy/radiotherapy, radionuclide therapy, or participation in other interventional clinical trials within the past 4 weeks;
4. Severe or uncontrolled cardiac, pulmonary, hepatic, or renal insufficiency, or active severe infection;
5. Bone marrow suppression not yet recovered (Hb \< 90 g/L, ANC \< 1.5 × 10⁹/L, platelets \< 100 × 10⁹/L);
6. Inability to complete imaging examinations such as PET/CT (e.g., severe claustrophobia, inability to lie supine for ≥ 30 min);
7. Any other situation deemed inappropriate for enrollment by the investigator.
2. Pregnancy or lactation;
3. Receipt of high-dose chemotherapy/radiotherapy, radionuclide therapy, or participation in other interventional clinical trials within the past 4 weeks;
4. Severe or uncontrolled cardiac, pulmonary, hepatic, or renal insufficiency, or active severe infection;
5. Bone marrow suppression not yet recovered (Hb \< 90 g/L, ANC \< 1.5 × 10⁹/L, platelets \< 100 × 10⁹/L);
6. Inability to complete imaging examinations such as PET/CT (e.g., severe claustrophobia, inability to lie supine for ≥ 30 min);
7. Any other situation deemed inappropriate for enrollment by the investigator.
Maximum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Jiangsu Province Hospital of Traditional Chinese Medicine
OTHER
Sponsor Role
collaborator
Nanjing First Hospital, Nanjing Medical University
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Guoqiang Shao, Dr
Role: STUDY_CHAIR
Nanjing First Hospital, Nanjing Medical University
Locations
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Nanjing First Hospital
Nanjing, Jiangsu, China
Site Status
RECRUITING
Countries
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China
Central Contacts
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Facility Contacts
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References
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Matthay KK, Shulkin B, Ladenstein R, Michon J, Giammarile F, Lewington V, Pearson AD, Cohn SL. Criteria for evaluation of disease extent by (123)I-metaiodobenzylguanidine scans in neuroblastoma: a report for the International Neuroblastoma Risk Group (INRG) Task Force. Br J Cancer. 2010 Apr 27;102(9):1319-26. doi: 10.1038/sj.bjc.6605621.
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Liu B, Zhuang H, Servaes S. Comparison of [123I]MIBG and [131I]MIBG for imaging of neuroblastoma and other neural crest tumors. Q J Nucl Med Mol Imaging. 2013 Mar;57(1):21-8.
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Bombardieri E, Giammarile F, Aktolun C, Baum RP, Bischof Delaloye A, Maffioli L, Moncayo R, Mortelmans L, Pepe G, Reske SN, Castellani MR, Chiti A; European Association for Nuclear Medicine. 131I/123I-metaiodobenzylguanidine (mIBG) scintigraphy: procedure guidelines for tumour imaging. Eur J Nucl Med Mol Imaging. 2010 Dec;37(12):2436-46. doi: 10.1007/s00259-010-1545-7.
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Frazier AA. Radiologic-Pathologic Features to Discern Nonepithelial versus Epithelial Pancreatic Tumors. Radiographics. 2016 Jan-Feb;36(1):122. doi: 10.1148/rg.2016154023. No abstract available.
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Sharp SE, Shulkin BL, Gelfand MJ, Salisbury S, Furman WL. 123I-MIBG scintigraphy and 18F-FDG PET in neuroblastoma. J Nucl Med. 2009 Aug;50(8):1237-43. doi: 10.2967/jnumed.108.060467. Epub 2009 Jul 17.
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Giammarile F, Chiti A, Lassmann M, Brans B, Flux G; EANM. EANM procedure guidelines for 131I-meta-iodobenzylguanidine (131I-mIBG) therapy. Eur J Nucl Med Mol Imaging. 2008 May;35(5):1039-47. doi: 10.1007/s00259-008-0715-3.
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Shulkin BL, Shapiro B. Current concepts on the diagnostic use of MIBG in children. J Nucl Med. 1998 Apr;39(4):679-88.
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BACKGROUND
Sharp SE, Trout AT, Weiss BD, Gelfand MJ. MIBG in Neuroblastoma Diagnostic Imaging and Therapy. Radiographics. 2016 Jan-Feb;36(1):258-78. doi: 10.1148/rg.2016150099.
Reference Type
BACKGROUND
Other Identifiers
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KY20220701-01
Identifier Type: -
Identifier Source: org_study_id
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PHASE2
A Clinical Study of 9MW2821 in Advanced Malignant Solid Tumors
NCT05773937
RECRUITING
PHASE1
A Study of LXI-15029 in Patients With Advanced Malignant Solid Tumors
NCT03125746
UNKNOWN
PHASE1
Endostar Durative Transfusion Combining With Gemcitabine-Cisplatin to Treat Non-Small Cell Lung Cancer (NSCLC)
NCT01669707
UNKNOWN
PHASE2
Precise Guidance of Adaptive Radiotherapy for Nasopharyngeal Carcinomar
NCT07137052
NOT_YET_RECRUITING
Evaluating the Safety, Tolerability, and Preliminary Anti-tumor Activity of MB0151 in Adult Subjects With Advanced Solid Tumors Expressing Somatostatin Receptors
NCT06840821
RECRUITING
PHASE1/PHASE2
The Value of 68Ga-grazytracer PET in Monitoring Responses to Immunotherapy of Advanced Soft Tissue Sarcomas
NCT06644287
RECRUITING
Adding Of Naxitamb In Induction Therapy For High Risk Neuroblastoma
NCT06574698
RECRUITING
Endostar Combined With Induction Chemotherapy and Concurrent Chemoradiotherapy for Locoregional Nasopharyngeal Carcinoma
NCT03932266
UNKNOWN
PHASE2
Effect of Endostar Combined With Chemotherapy and Radiotherapy on Blood Vessels and Microenvironment of Tumor for Non-small Cell Lung Cancer (NSCLC)
NCT01687439
COMPLETED
PHASE2
Induction Chemotherapy Followed by IMRT or Concurrent Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma
NCT05527470
RECRUITING
PHASE3
Induction Chemotherapy Followed By Chrono-chemotherapy Concurrent With IMRT Of Locally Advanced NPC Clinical Study
NCT02187315
UNKNOWN
PHASE2
Endostar Aggressive Treatment of Peripheral T-cell Lymphoma (PTCL) Phase II Clinical Study
NCT02520219
UNKNOWN
PHASE2
Treatment of Advanced Solid Tumors With Neo-T(GI-NeoT-02)
NCT05798546
UNKNOWN
PHASE1