Al18F-NOTA-octreotide PET Imaging in Neuroendocrine Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-07

Study Completion Date

2022-02-08

Brief Summary

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The aim of this study is to evaluate the diagnostic performance of Al18F-NOTA-octreotide PET imaging in comparison with the current golden standard, 68Ga-DOTA-somatostatin analog PET, in neuroendocrine tumor patients.

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Detailed Description

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Part A (main part of the trial):

Seventy-five neuroendocrine tumor (NET) patients (M/F, aged 18 years and older) with a routine clinical 68Ga-DOTA-somatostin analog (SSA) PET/CT performed in the last three months or scheduled within three months, will undergo a whole-body Al18F-NOTA-octreotide PET/CT.

Part B:

At least 10, possibly up to 20 NET patients (M/F, aged 18 years and older) with a routine clinical 68Ga-DOTA-SSA PET/CT performed in the last three months or scheduled within three months, will undergo a whole-body Al18F-NOTA-octreotide PET/MR.

Conditions

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Neuroendocrine Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients

In the main part of the trial (part A) 75 patients with cytologically and/or histologically confirmed neuroendocrine tumors of all grades of gastroenteropancreatic, pulmonary, neural crest or unknown primary origin will receive a single intravenous injection of Al18F-NOTA-octreotide. At two hours after tracer injection they will undergo a whole-body PET/CT scan.

In part B of the trial 10 up to 20 patients with with cytologically and/or histologically confirmed neuroendocrine tumors of all grades of gastroenteropancreatic, pulmonary, neural crest or unknown primary origin will receive a single intravenous injection of Al18F-NOTA-octreotide. At two hours after tracer injection they will undergo a whole-body PET/MR scan.

Group Type EXPERIMENTAL

Al18F-NOTA-octreotide

Intervention Type DRUG

One intravenous injection of 4 MBq/kg

PET/CT

Intervention Type DEVICE

Patients in part A of the trial will undergo a whole-body PET/CT scan 120 minutes (acceptable range: 105 - 240 minutes) after injection of the tracer. The CT-scan is a low-dose CT that will be acquired for both PET attenuation correction and anatomical information.

PET/MR

Intervention Type DEVICE

Patients in part B of the trial will undergo a whole-body PET/MR scan 120 minutes (acceptable range: 105 - 240 minutes) after injection of the tracer. The MR scan is a fully diagnostic MR requiring intravenous contrast (Dotarem®) injection and Buscopan® administration to minimize bowel movement.

Interventions

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Al18F-NOTA-octreotide

One intravenous injection of 4 MBq/kg

Intervention Type DRUG

PET/CT

Patients in part A of the trial will undergo a whole-body PET/CT scan 120 minutes (acceptable range: 105 - 240 minutes) after injection of the tracer. The CT-scan is a low-dose CT that will be acquired for both PET attenuation correction and anatomical information.

Intervention Type DEVICE

PET/MR

Patients in part B of the trial will undergo a whole-body PET/MR scan 120 minutes (acceptable range: 105 - 240 minutes) after injection of the tracer. The MR scan is a fully diagnostic MR requiring intravenous contrast (Dotarem®) injection and Buscopan® administration to minimize bowel movement.

Intervention Type DEVICE

Other Intervention Names

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18F-AlF-NOTA-octreotide 18F-IMP-466

Eligibility Criteria

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Inclusion Criteria

* Subject is aged over 18 years.
* Signed Informed Consent.
* Subject is diagnosed with a histologically and/or cytologically confirmed neuroendocrine tumor of all grades of gastroenteropancreatic, pulmonary, neural crest or unknown primary origin.
* Subject should have at least one known tumoral lesion below the level of the submandibular and parotid glands with either a minimum size of 1 cm in at least one dimension on morphological imaging (CT, MRI, ultrasound), or a maximal standardized uptake value (SUVmax) of at least 10 on 68Ga-DOTA-SSA PET, in both cases performed within 4 months prior to study scan. A positive lesion is defined as a volume of increased tracer uptake compared to background, deemed to be caused by the presence of NET cells, and that is unlikely to be attributed to physiological or benign etiology (e.g. inflammation, blood pool retention, excretion, etc.).
* Subject should have a routine clinical 68Ga-DOTA-SSA PET/CT performed within three months prior to the study scan or scheduled within three months after the study scan.
* Female subjects should be (a) post-menopausal, or (b) surgically sterile, or (c) using effective contraceptive with negative pregnancy test.

Exclusion Criteria

Part A and B:

* Subject has a previous or ongoing recurrent or chronic disease, other than a neuroendocrine tumor, at high risk to interfere with the performance or evaluation of the trial according to the judgement of the investigator.
* Subject has had exposure to ionizing radiation (\> 1 mSv) in other research studies within the last 12 months.
* Subject has recently (\< 30 days or 5 times the plasma half-life of the investigated drug, whichever is longest) participated or is simultaneously participating in another prospective interventional clinical trial.
* Subject is unwilling to avoid unusual, unaccustomed, or strenuous physical activity (i.e. weight lifting, running, bicycling) beginning 4 days prior to tracer injection up to 1 day after tracer injection.
* Subject is potentially pregnant (urinary hCG test can be performed in case of doubt) or is breast-feeding.
* Subject is unwilling or unable to perform all of the study procedures, or is considered unsuitable in any way by the principal investigator.
* Subject does not understand the study procedure.
* Subject is mentally or legally incapacitated.

Only for part B:

* Subject has a contra-indication for MR scanning.
* Subject suffers from claustrophobia or cannot tolerate confinement during PET/MR scanning.
* Subject has an impaired renal function: estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73m² (the last known value may not date from more than 3 months prior to the study PET/MR; if not available a blood analysis may be performed as part of the trial).
* Subject suffers from diseases for which butylhyoscine bromide (Buscopan®) is contra-indicated: glaucoma, paralytic ileus, severe colitis ulcerosa or myasthenia gravis.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No