Neuroblastoma Clinical Trial
Official title:
18F-mFBG LAFOV PET/CT Compared to 123I-mIBG Scintigraphy SPECT/CT for Evaluation of Children With Neuroblastoma
This is a study evaluating the positron-emitting radiopharmaceutical 18F-mFBG compared to 123I-mIBG scintigraphy for imaging of neuroblastoma
This is a prospective study designed to assess the use of 18F-mFBG PET imaging compared to 123I-mIBG scintigraphy in subjects with known or presumed neuroblastoma. Eligible participants will have either histopathologically established diagnosis of neuroblastoma or a presumed diagnosis based on signs, symptoms, physical examination, imaging findings, and laboratory and genetic test results. Subjects will only be administered 18F-mFBG if they have undergone or are scheduled to undergo a 123I-mIBG within +/- 7 days of the date of the 18F-mFBG scan. Subjects should not have received any chemotherapy, immunotherapy or radiotherapy between the clinical and 18F-mFBG imaging studies. 18F-mFBG PET studies will be evaluated by 2 independent teams of blinded readers: a nuclear medicine physician and a radiologist, both specialized in pediatric nuclear medicine co-reading side-by side. The clinical 123I-mIBG is also evaluated by 2 independent teams of blinded readers: a nuclear medicine physician and a radiologist, both specialized in pediatric nuclear medicine co-reading side-by side. Blinded readers will record whether findings on 18F-mFBG and 123I-mIBG scans are consistent with neuroblastoma. Subject-level diagnostic performance will be assessed on the basis of differencies in lesion-counting between the blinded 18F-mFBG scan interpretation and the 123I-mIBG scan. In case of discrepancy, independently assessed by an Expert Panel. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00492167 -
Beta-Glucan and Monoclonal Antibody 3F8 in Treating Patients With Metastatic Neuroblastoma
|
Phase 1 | |
| Completed |
NCT04474678 -
Quality Improvement Project - "My Logbook! - I Know my Way Around!"; ("Mein Logbuch - Ich Kenne Mich Aus!")
|
N/A | |
| Terminated |
NCT00801931 -
Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03107988 -
NANT 2015-02: A Phase 1 Study of Lorlatinib (PF-06463922)
|
Phase 1 | |
| Recruiting |
NCT04253015 -
A Post-Authorisation Safety Study Patient Registry of Patients With Neuroblastoma Being Treated With Dinutuximab Beta
|
||
| Terminated |
NCT00788125 -
Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors
|
Phase 1/Phase 2 | |
| Completed |
NCT03273712 -
Dosimetry-Guided, Peptide Receptor Radiotherapy (PRRT) With 90Y-DOTA- tyr3-Octreotide (90Y-DOTATOC)
|
Phase 2 | |
| Recruiting |
NCT02933333 -
G-CSF Alone or Combination With GM-CSF on Prevention and Treatment of Infection in Children With Malignant Tumor
|
Phase 4 | |
| Recruiting |
NCT00588068 -
Molecular Characterization of Neuroblastic Tumor: Correlation With Clinical Outcome
|
||
| Recruiting |
NCT04301843 -
Eflornithine (DFMO) and Etoposide for Relapsed/Refractory Neuroblastoma
|
Phase 2 | |
| Completed |
NCT00026780 -
Eligibility Screening for a NCI Pediatric Oncology Branch Research Study
|
||
| Recruiting |
NCT04040088 -
An Investigational Scan (68Ga-DOTATATE PET/CT) in Diagnosing Pediatric Metastatic Neuroendocrine Tumors
|
Early Phase 1 | |
| Recruiting |
NCT06057948 -
A Study of a Vaccine in Combination With Beta-glucan in People With Neuroblastoma
|
Phase 2 | |
| Not yet recruiting |
NCT06335745 -
PediCARE Health Equity Intervention in High-Risk Neuroblastoma
|
N/A | |
| Recruiting |
NCT02559778 -
Pediatric Precision Laboratory Advanced Neuroblastoma Therapy
|
Phase 2 | |
| Completed |
NCT02441062 -
Impact of Ga-68 DOTATOC PET-CT Imaging in Management of Neuroendocrine Tumors
|
Phase 2 | |
| Active, not recruiting |
NCT02245997 -
Local Control With Reduced-dose Radiotherapy for High-Risk Neuroblastoma
|
N/A | |
| Not yet recruiting |
NCT01156350 -
Haplo-identical Hematopoietic Stem Cell Transplantation Following Reduced-intensity Conditioning in Children With Neuroblastoma
|
Phase 2 | |
| Active, not recruiting |
NCT01192555 -
Allogeneic Tumor Cell Vaccination With Oral Metronomic Cytoxan in Patients With High-Risk Neuroblastoma
|
Phase 1/Phase 2 | |
| Completed |
NCT01222780 -
To Evaluate the Safety, Activity and Pharmacokinetics of Marqibo in Children and Adolescents With Refractory Cancer
|
Phase 1 |