NCT03883776

Brief Summary

The aim of this study is to evaluate the potential of Al18F-1,4,7-triazacyclononane-1,4,7-triacetate-octreotide (Al18F-NOTA-octreotide) as a positron emission tomography (PET) somatostatin receptor imaging agent in patients with neuroendocrine tumors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2019

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 21, 2019

Completed
21 days until next milestone

Study Start

First participant enrolled

April 11, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2019

Completed
Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

7 months

First QC Date

March 13, 2019

Last Update Submit

September 3, 2020

Conditions

Neuroendocrine Tumors

Keywords

PET/CTSomatostatin receptor imagingAl18F-NOTA-octreotide

Outcome Measures

Primary Outcomes (1)

  • Potential of Al18F-NOTA-octreotide as somatostatin receptor PET imaging tracer in patients with neuroendocrine tumors

    The primary endpoint will be met if in 4 out of 6 patients, at least two tumor lesions per patient are visualized in case of 5 to 10 known positive lesions on the 68Ga-DOTA-peptide PET, or at least 25% of the known tumor lesions per patient are visualized in case of more than 10 known positive tumor lesions on the 68Ga-DOTA-peptide PET. The study will be partially positive if in at least one patient at least 80% of the known positive lesions on the 68Ga-DOTA-peptide PET is visualized.

    1 year

Secondary Outcomes (5)

  • Dosimetry of Al18F-NOTA-octreotide

    1 year

  • Normal-organ and tumor uptake of Al18F-NOTA-octreotide as a function of time

    1 year

  • Identify the ideal time point for imaging after Al18F-NOTA-octreotide injection

    1 year

  • Safety analysis of Al18F-NOTA-octreotide administration: Common Terminology Criteria for Adverse Events (CTCAE) version 4.03

    1 year

  • Preliminary assessment of lesion targeting by Al18F-NOTA-octreotide as compared to 68Ga-DOTATATE

    1 year

Study Arms (1)

healthy volunteers and NET patients

EXPERIMENTAL

In the first part of the study, 6 healthy volunteers will receive a single intravenous single injection of Al18F-NOTA-octreotide, followed by whole-body PET/CT scans at various time points for an initial safety assessment and dosimetry study. In the second part of the study, a single dose of Al18F-NOTA-octreotide will be intravenously injected in 6 patients with neuroendocrine tumors. Patients will first undergo a dynamic PET scan, followed by whole-body PET/CT scans at various time points for a pharmacokinetics study and initial efficacy assessment.

Drug: Al18F-NOTA-octreotideDevice: PET/CTOther: Venous blood samples

Interventions

Al18F-NOTA-octreotideDRUG

One intravenous injection of 4 MBq/kg

Also known as: 18F-AlF-NOTA-octreotide, 18F-IMP-466
healthy volunteers and NET patients
PET/CTDEVICE

Part 1: Healthy volunteers will undergo consecutive whole-body PET scans, including one low-dose CT, for the first 90 minutes. At 150 ± 15 min and 300 ± 30 min post injection two additional static whole-body PET/CT scans will be acquired. Part 2: Neuroendocrine tumor patients will undergo a dynamic PET scan for the first 45 minutes, followed by 3 static whole-body PET/CTs at 60 ± 10 min, 120 ± 30 min and 180 ± 30 min post injection.

healthy volunteers and NET patients
Venous blood samplesOTHER

Blood samples will be obtained for laboratory safety evaluation for initial screening and safety evaluation after injection. Furthermore, venous blood samples will be obtained for metabolite analysis and activity measurements (only for patients) at various time points post injection (5 ± 2 min, 10 ± 5 min, 20 ± 10 min, 40 ± 20 min, 60 ± 30 min, 120 ± 60 min).

healthy volunteers and NET patients

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Part 1: Healthy volunteers:
  • Age between 18 and 65 years
  • Signed Informed Consent
  • Subject is judged to be in good health by the investigator on the basis of medical history, physical examination including vital signs and clinical laboratory tests
  • Female subjects should be post-menopausal or surgically sterile or using effective contraceptive with negative urinary pregnancy test
  • Part 2: Neuroendocrine tumor patients:
  • Age between 18 and 75 years
  • Signed Informed Consent
  • Subject is diagnosed with a neuroendocrine tumor of gastroenteropancreatic, pulmonary, neural crest or unknown primary origin
  • Subject is judged to be in good general condition by the investigator on the basis of medical history, physical examination including vital signs and clinical laboratory tests, besides the diagnosis of neuroendocrine tumor.
  • Female subjects should be post-menopausal or surgically sterile or using effective contraceptive with negative pregnancy test

You may not qualify if:

  • Part 1: Healthy volunteers:
  • Subject has a previous or ongoing recurrent or chronic disease able to interfere with the evaluation of the trial according to the judgement of the investigator, especially a known gastro-intestinal, hepatic, renal, cardiovascular, metabolic or hormonal disease, cancer, major neurological or convulsive disorder or any psychiatric disease
  • Subject is currently a user (including ''recreational use'') of any illicit drugs, including cannabis, or has a history of drug or alcohol abuse
  • Subject takes concomitant medication, except for oral contraceptives, sporadic paracetamol, or low-dose and limited in time non-steroidal antiinflammatory drugs
  • Subject is unable to refrain from smoking more than 10 cigarettes per day during the study
  • Subject has had exposure to ionizing radiation (\> 1 mSv) in other research studies within the last 12 months
  • Subject suffers from claustrophobia or cannot tolerate confinement during PET/CT scanning procedures; subject cannot lie still for 90 minutes inside the scanner
  • Subject is unwilling to avoid unusual, unaccustomed, or strenuous physical activity (i.e. weight lifting, running, bicycling) from the time of the selection visit until the safety visit
  • Subject does not understand the study procedure
  • Subject is unwilling or unable to perform all of the study procedures, or is considered unsuitable in any way by the principal investigator
  • Subject is potentially pregnant (urinary hCG test will be performed in women where pregnancy is not excluded), wishes to become pregnant up to 3 months after administration of Al18F-NOTA-octreotide or is breast-feeding
  • Subject has recently (\< 30 days) participated or is simultaneously participating in another prospective interventional clinical trial
  • Subject has a history of multiple and/or severe allergies to drugs or food
  • Subject is mentally or legally incapacitated
  • Part 2: Neuroendocrine tumor patients:
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitaire Ziekenhuizen Leuven

Leuven, 3000, Belgium

Location

Related Publications (1)

  • Pauwels E, Cleeren F, Tshibangu T, Koole M, Serdons K, Dekervel J, Van Cutsem E, Verslype C, Van Laere K, Bormans G, Deroose CM. [18F]AlF-NOTA-octreotide PET imaging: biodistribution, dosimetry and first comparison with [68Ga]Ga-DOTATATE in neuroendocrine tumour patients. Eur J Nucl Med Mol Imaging. 2020 Dec;47(13):3033-3046. doi: 10.1007/s00259-020-04918-4. Epub 2020 Jul 2.

    PMID: 32617641RESULT

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

Al18F-NOTA-octreotidePositron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Positron-Emission TomographyTomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomography, X-Ray ComputedMultimodal ImagingRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayRadionuclide ImagingTomographyDiagnostic Techniques, Radioisotope

Study Officials

  • Christophe Deroose, MD, PhD

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2019

First Posted

March 21, 2019

Study Start

April 11, 2019

Primary Completion

October 29, 2019

Study Completion

October 29, 2019

Last Updated

September 9, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)