A Phase I/II Study of [124I]mIBG PET/CT in Neuroblastoma
Verified September 2015 by Cancer Research UK
Information provided by (Responsible Party):
Cancer Research UK
First received: January 21, 2014
Last updated: September 7, 2015
Last verified: September 2015
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).
Metastatic Neuroblastoma (Stage 4 on International Neuroblastoma Staging System (INSS))
||Primary Purpose: Treatment
||A Cancer Research UK Phase I/II Study to Compare [124I]Meta-Iodobenzylguanidine (mIBG) Positron Emission Tomography/Computerised Tomography (PET/CT) to [123I]mIBG Imaging in Patients With Metastatic Neuroblastoma
Primary Outcome Measures:
Secondary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||October 2018 (Final data collection date for primary outcome measure)
Single intravenous administration of [124I]mIBG Solution for Injection on Day 1 with a maximum radioactive dose of 1.42 MBq/kg (±10%) and a maximum injected dose of 50 MBq [124I]mIBG equating to a maximum chemical dose of 10 micrograms of stable mIBG. The activity to paediatric patients will be scaled by weight based upon the EANM paediatric dose card (Lassmann et al., 2007). This will result in an activity between 10 MBq and 50 MBq depending on the patient's weight.
Neuroblastoma is the most common tumour of childhood after brain tumours. Approximately half of cases are high risk and despite extensive treatments outcome is very poor. More than 60% of high risk patients suffer relapse or further spread of their disease and long-term survival is below 10%. Existing imaging techniques are not sensitive enough to accurately assess the level of risk which is critical in determining the best choice of treatment. This study will compare a new type of imaging against the existing imaging techniques. The new scans use a new tracer called [124I]mIBG which is taken up by the cancer tissue much more than by normal tissues. This tracer can be used with a 3D imaging technique called PET/CT to pinpoint where the disease has spread and quantify the amount of disease. Patients will be those scheduled to have an [123I]mIBG scan for routine care during a planned break in treatment.
|Ages Eligible for Study:
||1 Year and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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 (Appendix 2) for patients aged > 12 years old or Lansky play scale score of ≥ 50% (Appendix 3) 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 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).
Additional Inclusion Criteria for Biokinetic sub-study
- Aged ≤ 16 years at the time that written informed consent is given.
- No requirement for general anaesthesia to undergo PET/CT scanning.
- Written (signed and dated) informed consent for the sub-study from patients aged 16 years or from the patient's parent or guardian for patients aged <16 years. Capable of co-operating with the additional study PET/CT scans. (N.B. Written or verbal assent as appropriate should be sought from all patients who are under 16 years old.)
Additional Inclusion Criteria for PET/MRI sub-study
- No requirement for general anaesthesia to undergo hybrid PET/MRI scanning.
- No previous experience of claustrophobia.
- Written (signed and dated) informed consent for the sub-study from patients aged 16 years or from the patient's parent or guardian for patients aged <16 years. Capable of co-operating with the additional study PET/MRI scans. (N.B. Written or verbal assent as appropriate should be sought from all patients who are under 16 years old.)
- Treatment with any medications contra-indicated with mIBG scanning as listed in Appendix 4. 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).
- Stage 4S neuroblastoma as defined by the INSS.
- 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.
- Female patients who are pregnant or lactating.
- At high medical risk because of non-malignant systemic disease including active uncontrolled infection.
- Known to be serologically positive for Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV).
- Patients with known hypersensitivity to mIBG.
- Any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical study.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02043899
|University College London Hospital
|London, United Kingdom, NW1 2PG |
|Contact: Contact Person email@example.com |
|Principal Investigator: Mark Gaze, Dr |
|Royal Marsden Hospital
|Sutton, United Kingdom, SM2 5PT |
|Contact: Contact Person firstname.lastname@example.org |
|Principal Investigator: Sucheta Vaidya, Dr |
Cancer Research UK
No publications provided
||Cancer Research UK
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 21, 2014
||September 7, 2015
||United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
Keywords provided by Cancer Research UK:
Positron emission tomography
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 06, 2015
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neuroectodermal Tumors, Primitive
Neuroectodermal Tumors, Primitive, Peripheral
Diagnostic Uses of Chemicals
Molecular Mechanisms of Pharmacological Action