| Eligibility |
Inclusion Criteria:
1. Histologically proven Stage 4 neuroblastoma as defined by the International
Neuroblastoma Staging System (INSS).
2. Aged = 1 year at the time that written informed consent is given.
3. Planned to undergo conventional [123I]mIBG planar scintigraphy for routine clinical
care of neuroblastoma.
4. Life expectancy of at least 12 weeks.
5. 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.
6. Written (signed and dated) informed consent from patient = 16 years old and/or parent
or legal guardian for patients <16 years old and the patient be capable of
co-operating with scanning requirements. (N.B. Written or verbal assent as appropriate
should be sought from all patients who are under 16 years old).
Exclusion Criteria:
1. Treatment with any medications contra-indicated with mIBG scanning as listed in
Appendix 4 of the trial protocol. For example, decongestants containing
pseudoephedrine, phenylpropalomine and phenylephrine, sympathomimetics, cocaine,
antihypertensives, tricyclic antidepressants. These drugs should be stopped before
administration as indicated in this list (usually for four biological half-lives to
allow almost complete wash-out but refer to list).
2. Stage 4S neuroblastoma as defined by the INSS.
3. Any anti-cancer treatment planned between the routine [123I]mIBG imaging and the
[124I]mIBG PET/CT scan on Day 2. Anti-cancer treatments can be started only after the
Off-Study assessment on Day 3 to Day 7, see schedule of assessments in Section 7. N.B.
Patients should not be enrolled in the study if their participation will delay their
subsequent treatment for neuroblastoma.
4. Female patients who are pregnant or lactating.
5. At high medical risk because of non-malignant systemic disease including active
uncontrolled infection.
6. Known to be serologically positive for Hepatitis B, Hepatitis C or Human
Immunodeficiency Virus (HIV).
7. Patients with known hypersensitivity to mIBG.
8. Any other condition which in the Investigator's opinion would not make the patient a
good candidate for the clinical study.
Clinical Criteria for [124I]mIBG imaging
1. One or more disease foci observed on conventional [123I]mIBG planar scintigraphy.
Disease foci will initially be identified by a Nuclear Medicine physician at the
investigational site.
2. = 3kg at the time of the [124I]mIBG imaging to agree with the paediatric EANM
guidelines.
3. Haematological and biochemical indices within the ranges below:
For patients =16 years old, haematological and biochemical indices within the
following ranges: Haemoglobin = 7.0 g/dl (N.B transfusions will be allowed); Absolute
neutrophil count = 0.2 x 10^9/L (N.B. G-CSF support will be allowed); Platelet count =
10 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 Calculated creatinine clearance
using revised Schwartz formula = 60 mL/min/1.73m^2.
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.
4. 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.
5. 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.
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