A Phase I/II Study of [124I]mIBG PET/CT in Neuroblastoma

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by Cancer Research UK
Sponsor:
Information provided by (Responsible Party):
Cancer Research UK
ClinicalTrials.gov Identifier:
NCT02043899
First received: January 21, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted
  Purpose

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).


Condition Intervention Phase
Metastatic Neuroblastoma (Stage 4 on International Neuroblastoma Staging System (INSS))
Drug: [124I]meta-Iodobenzylguanidine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Cancer Research UK:

Primary Outcome Measures:
  • Comparison of the percentage of lesions detected as positive by [123I]mIBG planar scintigraphy which are also considered positive with [124I]mIBG PET/CT [ Time Frame: 3-14 days after routine [123I]mIBG ] [ Designated as safety issue: No ]
    Imaging data from each imaging modality will be read and scored separately by four expert Nuclear Medicine clinicians following receipt of a complete set of data for each patient.


Secondary Outcome Measures:
  • Assessing the safety and toxicity profile of a single intravenous administration of [124I]mIBG [ Time Frame: Consent to Day 3 - 7 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 25
Study Start Date: February 2014
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: [124I]meta-Iodobenzylguanidine
    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.
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 (Appendix 2) for patients aged > 12 years old or Lansky play scale score of ≥ 50% (Appendix 3) 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).

Additional Inclusion Criteria for Biokinetic sub-study

  1. Aged ≤ 16 years at the time that written informed consent is given.
  2. No requirement for general anaesthesia to undergo PET/CT scanning.
  3. 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

  1. No requirement for general anaesthesia to undergo hybrid PET/MRI scanning.
  2. No previous experience of claustrophobia.
  3. 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.)

Exclusion Criteria:

  1. 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).
  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.
  Contacts and Locations
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

Locations
United Kingdom
University College London Hospital Not yet recruiting
London, United Kingdom, NW1 2PG
Contact: Contact Person       mark.gaze@uclh.nhs.uk   
Principal Investigator: Mark Gaze, Dr         
Royal Marsden Hospital Not yet recruiting
Sutton, United Kingdom, SM2 5PT
Contact: Cotact Person       andrew.pearson@icr.ac.uk   
Principal Investigator: Andrew DJ Pearson, Prof         
Sponsors and Collaborators
Cancer Research UK
  More Information

No publications provided

Responsible Party: Cancer Research UK
ClinicalTrials.gov Identifier: NCT02043899     History of Changes
Other Study ID Numbers: CRUKD/12/002
Study First Received: January 21, 2014
Last Updated: January 21, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Keywords provided by Cancer Research UK:
Neuroblastoma
Positron emission tomography
124-iodine
Meta-Iodobenzylguanidine

Additional relevant MeSH terms:
Neuroblastoma
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
3-Iodobenzylguanidine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Radiopharmaceuticals
Diagnostic Uses of Chemicals

ClinicalTrials.gov processed this record on August 28, 2014