Neuroendocrine TumorsPhase 1NCT03883776

Al18F-NOTA-octreotide PET Imaging of the Somatostatin Receptor in Neuroendocrine Tumors

A Phase 1 study testing Al18F-NOTA-octreotide, PET/CT and Venous blood samples in people with Neuroendocrine Tumors, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Neuroendocrine Tumors
What is being tested?: Al18F-NOTA-octreotide, PET/CT and Venous blood samples
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteBelgium
Study dates: 11 Apr 2019to 29 Oct 2019
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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:

Show all 12Show fewer

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.
Subject should have at least 5 positive lesions on routine clinical 68Ga-DOTA-peptide PET performed within 6 months prior to the inclusion visit. A positive lesion is defined as tracer uptake above background deemed to be caused by the presence of NET cells by an experienced nuclear medicine physician
Female subjects should be post-menopausal or surgically sterile or using effective contraceptive with negative pregnancy test

Who cannot join

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

Show all 29Show fewer

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 underwent surgery between the selection and inclusion visit
Subject is mentally or legally incapacitated
Part 2: Neuroendocrine tumor patients:
Subject has a previous or ongoing recurrent or chronic disease, other than a neuroendocrine tumor, at high risk to interfere with the evaluation of the trial according to the judgement of the investigator, e.g. 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 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 60 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 telephone follow-up interview.
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 underwent surgery between the selection and inclusion visit
Subject is mentally or legally incapacitated

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Universitaire Ziekenhuizen Leuven
Leuven, 3000

Other trials in Belgium

About this study

Official title: Al18F-NOTA-octreotide PET Imaging of the Somatostatin Receptor in Neuroendocrine Tumors: a First-in-human PET/CT Study

Read the detailed description

In the first part of the study, six healthy volunteers will undergo several sequential whole-body PET/CT scans starting from the moment of tracer injection up to six hours post injection for an initial safety assessment and dosimetry study of Al18F-NOTA-octreotide in humans.

In the second part of the study, six neuroendocrine tumor patients, with at least five positive lesions on routine clinical 68Ga-DOTA-peptide PET, will undergo a dynamic PET scan for the first 45 minutes, followed by three single static whole-body PET/CTs up to three hours post injection for an initial efficacy assessment (evaluation of the lesion detection rate) and pharmacokinetics study of Al18F-NOTA-octreotide in humans. Furthermore a first comparison with 68Ga-DOTA peptide PET will be performed.

Conditions: Neuroendocrine Tumors
Being tested: Al18F-NOTA-octreotide, PET/CT, Venous blood samples
Keywords: PET/CT, Somatostatin receptor imaging, Al18F-NOTA-octreotide
Medical subject headings: Neuroendocrine Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Al18F-NOTA-octreotideDrug
Also called 18F-AlF-NOTA-octreotide, 18F-IMP-466
One intravenous injection of 4 MBq/kg
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.
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).

Study groups in NCT03883776
Study group	Role	What they receive
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. Receives: Drug: Al18F-NOTA-octreotide; Device: PET/CT; Other: Venous blood samples

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 1 year

Secondary outcomes (5)

Dosimetry of Al18F-NOTA-octreotide
Dosimetry will be assessed by means of the sequential whole-body PET/CT scans performed in healthy volunteers. Absorbed dose per unit of injected activity (mGy/MBq) at the organ and whole-body level will be calculated.
Measured: 1 year
Normal-organ and tumor uptake of Al18F-NOTA-octreotide as a function of time
Patients will undergo dynamic PET scanning followed by three static whole-body PET/CT scans at different time points post injection. Uptake as a function of time (pharmacokinetics) will be studied using the software package PMOD (PMOD technologies LLC, Zürich, Switzerland). Volumes of interest (VOIs) will be delineated in relevant normal organs and tumor lesions on all PET images and standardized uptake values (SUV) in all these VOIs will be measured to compute normal-organ and tumor uptake as a function of time.
Measured: 1 year
Identify the ideal time point for imaging after Al18F-NOTA-octreotide injection
Tumor-to-background ratios as a function of time will be measured. The time point resulting in optimal tumor-to-background ratios, taking into account a realistic implementation in clinical practice, will be defined as the ideal time point for imaging.
Measured: 1 year
Safety analysis of Al18F-NOTA-octreotide administration: Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
The impact of Al18F-NOTA-octreotide administration on clinical symptoms and signs and biochemistry values will be evaluated. Baseline values will be recorded and patients will be assessed clinically and with serial biochemical analysis. Adverse events will be scored according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Measured: 1 year
Preliminary assessment of lesion targeting by Al18F-NOTA-octreotide as compared to 68Ga-DOTATATE
A lesion-by-lesion analysis (visual and semi-quantitative) will be performed to compare the number of detected lesions using both tracers.
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Apr 201929 Oct 2019

First posted21 Mar 2019
Study start11 Apr 2019
Primary completion29 Oct 2019
Study completion29 Oct 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03883776
Sponsor's protocol ID: S61727
Status last verified: Sep 2020
First submitted: 13 Mar 2019
Last updated: 9 Sep 2020
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 32617641

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Neuroendocrine Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Al18F-NOTA-octreotide PET Imaging of the Somatostatin Receptor in Neuroendocrine Tumors: a First-in-human PET/CT Study
ClinicalTrials.gov ID: NCT03883776
Acronym / sponsor ID: S61727
Conditions: Neuroendocrine Tumors
Keywords: PET/CT, Somatostatin receptor imaging, Al18F-NOTA-octreotide
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
Study start: 11 Apr 2019 (actual)
Primary completion: 29 Oct 2019 (actual)
Study completion: 29 Oct 2019 (actual)
First posted: 21 Mar 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
healthy volunteers and NET patients	Experimental	Drug: Al18F-NOTA-octreotide, Device: PET/CT, Other: Venous blood samplesIn 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.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

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
Age between 18 and 75 years

Key exclusion criteria (29 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Al18F-NOTA-octreotideAlso: 18F-AlF-NOTA-octreotide, 18F-IMP-466One intravenous injection of 4 MBq/kg	Drug	healthy volunteers and NET patients
PET/CTPart 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.	Device	healthy volunteers and NET patients
Venous blood samplesBlood 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).	Other	healthy volunteers and NET patients

Primary outcome

Potential of Al18F-NOTA-octreotide as somatostatin receptor PET imaging tracer in patients with neuroendocrine tumors
Time frame: 1 year
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.

5 secondary outcomes

Dosimetry of Al18F-NOTA-octreotide
Time frame: 1 year
Normal-organ and tumor uptake of Al18F-NOTA-octreotide as a function of time
Time frame: 1 year
Identify the ideal time point for imaging after Al18F-NOTA-octreotide injection
Time frame: 1 year
Safety analysis of Al18F-NOTA-octreotide administration: Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
Time frame: 1 year
Preliminary assessment of lesion targeting by Al18F-NOTA-octreotide as compared to 68Ga-DOTATATE
Time frame: 1 year

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
Results publication: PubMed 32617641Pauwels 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.
Individual participant dataSharing planned: No

Related trials for Neuroendocrine Tumors

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IL-17 Blockade to Decrease irAEs (REPLAY)
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A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christophe Deroose, MD, PhD principal investigator

Universitaire Ziekenhuizen KU Leuven

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Al18F-NOTA-octreotide, PET/CT and Venous blood samples in people with Neuroendocrine Tumors, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Potential of Al18F-NOTA-octreotide as somatostatin receptor PET imaging tracer in patients with neuroendocrine tumors (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03883776, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.