Phase 2
N=36
A Phase I/II Study of [124I]mIBG PET/CT in Neuroblastoma
Metastatic Neuroblastoma
Bottom Line
View on ClinicalTrials.gov: NCT02043899 ↗Enrolled (actual)
36
Serious AEs
6.3%
Results posted
Jun 2021
Primary outcome: Primary: Comparison of the Number of Lesions Detected as Positive by [123I]mIBG Planar Scintigraphy Which Are Also Considered Positive With [124I]mIBG PET/CT. — 714; 405 Lesions — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- [124I]meta-Iodobenzylguanidine (Drug)
- Age
- Pediatric, Adult, Older Adult · 1+ yrs
- Sex
- All
- Sponsor
- Cancer Research UK
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of the Number of Lesions Detected as Positive by [123I]mIBG Planar Scintigraphy Which Are Also Considered Positive With [124I]mIBG PET/CT. |
714; 405 | <0.001 sig |
| SECONDARY Comparison of the Number of Lesions Detected as Positive by [123I]mIBG SPECT Which Are Also Considered Positive With [124I]mIBG PET/CT. |
421; 249; 132; 64 | — |
| SECONDARY Determining the Causality of Each Adverse Event to [124I]mIBG and Grading Severity According to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.02. |
25; 16; 9; 3; 0; 0 | — |
Summary
This study aims to show that 3-dimensional PET/CT imaging with a new novel PET tracer (called [124I]mIBG) can detect as many or more sites of neuroblastoma (a type of childhood cancer) compared to the recommended 1-dimensional routine scans (called [123I]mIBG planar scintigraphy).
Eligibility Criteria
Inclusion Criteria
- Histologically proven Stage 4 neuroblastoma as defined by the International Neuroblastoma Staging System (INSS).
- Aged ≥ 1 year at the time that written informed consent is given.
- Planned to undergo conventional [123I]mIBG planar scintigraphy for routine clinical care of neuroblastoma.
- Life expectancy of at least 12 weeks.
- World Health Organisation (WHO) performance status of 0, 1 or 2 for patients aged > 12 years old or Lansky play scale score of ≥ 50% for patients aged ≤ 12 years old.
- Written (signed and dated) informed consent from patient ≥ 16 years old and/or parent or legal guardian for patients 16 years old, haematological and biochemical indices within the following ranges: Haemoglobin ≥ 8.0 g/dl (N.B transfusions will be allowed); Absolute neutrophil count ≥ 0.5 x 10^9/L (N.B. G-CSF support will be allowed); Platelet count ≥ 50 x 10^9/L (N.B. transfusions will be allowed); Serum bilirubin ≤ 2.5 x upper limit of normal (ULN); Alanine amino-transferase (ALT), aspartate amino-transferase (AST), and/ or alkaline phosphatase (ALP) ≤ 5 x ULN; and Estimated Glomerular Filtration Rate (eGFR) ≥ 60 mL/min/1.73m^2.
- Menarchal female patients must have a negative serum or urine pregnancy test before administration of [124I]mIBG Solution for Injection on Day 1 and agree to use two highly effective forms of contraception (oral, injected or implanted hormonal contraception and condom, have an intra-uterine device and condom, diaphragm with spermicidal gel and condom) to be effective from Day 1 and for 7 days afterwards.
- Male patients with partners of child-bearing potential must agree to take measures not to father children by using one form of highly effective contraception [condom plus spermicide] from Day 1 and for 7 days afterwards. Male patients with pregnant or lactating partners must agree to use barrier method contraception (e.g. condom plus spermicidal gel) to prevent exposure to the foetus or neonate.
Data sourced from ClinicalTrials.gov (NCT02043899). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.