Clinical Trial Results:
Evaluation of [11C]-methionine positron emission computerised tomography (PET CT) in diagnosing neurofibromatosis 1(NF1) - malignant peripheral nerve sheath tumours (MPNST)
Summary
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EudraCT number |
2010-019759-23 |
Trial protocol |
GB |
Global end of trial date |
09 Jan 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
17 Oct 2018
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First version publication date |
17 Oct 2018
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Other versions |
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Summary report(s) |
FINAL STUDY REPORT |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
PET-CT140410
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Guy's and St Thomas' NHS Foundation Trust
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Sponsor organisation address |
Great Maze Pond, London, United Kingdom, SE19RT
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Public contact |
Professor Rosalie Ferner, Guy's and St Thomas' NHS Foundation Trust, 0044 02071883970 , rosalie.ferner@kcl.ac.uk
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Scientific contact |
Professor Rosalie Ferner, Guy's and St Thomas' NHS Foundation Trust, 0044 02071883970 , rosalie.ferner@kcl.ac.uk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
26 Aug 2013
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
26 Aug 2013
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Global end of trial reached? |
Yes
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Global end of trial date |
09 Jan 2014
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
1) To evaluate whether [11C]-methionine is more sensitive and specific than FDG PET CT in evaluating malignant transformation of plexiform neurofibromas in NF1 patients.
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Protection of trial subjects |
All patients will be followed for reporting of adverse events (AEs) from when the
informed consent is signed until the telephone call on the day following the PET CT. If
there are AEs that occurred while the patient was on study which are attributed (almost
certainly, probably or possibly imaging agent-related) to [11C]-methionine, and are still
present on the follow-up phone call, the patient will be followed monthly until resolution
or stabilisation of these events.
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Background therapy |
None | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
14 Feb 2012
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 5
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Worldwide total number of subjects |
5
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EEA total number of subjects |
5
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
5
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
5 subjects were recruited to this trial within the United Kingdom | ||||||
Pre-assignment
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Screening details |
Twenty two individuals were assessed & failed screening | ||||||
Period 1
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Period 1 title |
Study Intervention (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Arms
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Arm title
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All Participants | ||||||
Arm description |
AEs and concomitant medications must be assessed prior to administration of the first imaging agent [11C]-methionine. AEs must be assessed throughout the patient’s time in the PET Imaging Centre. [11C]-methionine imaging: • Patients must fast starting 4 hours prior to [11C]-methionine administration (Time = T0), until after their scan (Time = T0+1). Patients may drink water throughout this period of approximately 5 hours of fasting. • An intravenous injection of 800 MBq (± 10%) [11]C-methionine will be administered (Time = T0) in accordance with section 6.1.4 “[11C]-methionine Administration”. A 40-minute dynamic PET acquisition scan over the lesion will be performed. After this the patient may get up off the scanning couch, have a drink of water and use the toilet. | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
[11]C-methionine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Radiopharmaceutical precursor
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Routes of administration |
Intravenous bolus use
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Dosage and administration details |
intravenous injection of 800 MBq (± 10%) [11]C-methionine
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Baseline characteristics reporting groups
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Reporting group title |
Study Intervention
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
All Participants
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Reporting group description |
AEs and concomitant medications must be assessed prior to administration of the first imaging agent [11C]-methionine. AEs must be assessed throughout the patient’s time in the PET Imaging Centre. [11C]-methionine imaging: • Patients must fast starting 4 hours prior to [11C]-methionine administration (Time = T0), until after their scan (Time = T0+1). Patients may drink water throughout this period of approximately 5 hours of fasting. • An intravenous injection of 800 MBq (± 10%) [11]C-methionine will be administered (Time = T0) in accordance with section 6.1.4 “[11C]-methionine Administration”. A 40-minute dynamic PET acquisition scan over the lesion will be performed. After this the patient may get up off the scanning couch, have a drink of water and use the toilet. |
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End point title |
Primary Endpoint [1] | ||||||
End point description |
Evaluation of [11C]-Methionine PET CT in the diagnosis of neurofibromatosis 1 (NF1)- malignant peripheral nerve sheath tumours (MPNST). Improvement of identification of NF1 patients with malignant transformation of symptomatic plexiform neurofibromas compared with FDG PET CT.
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End point type |
Primary
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End point timeframe |
Duration of trial
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Trial was terminated early after only 5 participants enrolled. Please see attached document for results. |
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No statistical analyses for this end point |
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End point title |
Secondary Outco,es | ||||||
End point description |
To compare the semi-quantitative uptake of methionine with genetic analysis of the NF1- MPNST
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End point type |
Secondary
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End point timeframe |
Duration of trial interventions
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No statistical analyses for this end point |
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End point title |
Secondary Outcomes | ||||||
End point description |
To assess the safety of [11C]- methionine in patients with NF1 who are at risk of malignant transformation of plexiform neurofibromas to MPNST
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End point type |
Secondary
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End point timeframe |
Duration of trial intervention
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
From consent to post methionine until their Off-Study telephone assessment after
administration of [11C]-methionine.
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Assessment type |
Systematic | ||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||
Dictionary version |
17.1
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Reporting groups
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Reporting group title |
Whole Trial
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Reporting group description |
- | ||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
Trial was terminated early due to technical problems with inadequate yield of [11C]-Methionine & significant difficulties in recruiting patients with this rare disease complication with stringent inclusion criteria. 5 subjects were recruited only. |