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Neuroendocrine TumorsPhase 2/3NCT04552847

Al18F-NOTA-octreotide PET Imaging in Neuroendocrine Tumors

A Phase 2/3 study testing Al18F-NOTA-octreotide, PET/CT and PET/MR 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 diagnostic performance of Al18F-NOTA-octreotide PET imaging in comparison with the current golden standard, 68Ga-DOTA-somatostatin analog PET, in neuroendocrine tumor patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neuroendocrine Tumors
What is being tested?
Al18F-NOTA-octreotide, PET/CT and PET/MR
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
1 siteBelgium
Study dates
7 Oct 2020to 8 Feb 2022
Phase
Phase 2/3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

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

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.

Read the detailed description

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.

Being tested
Al18F-NOTA-octreotide, PET/CT, PET/MR
Keywords
Somatostatin receptor imaging, Al18F-NOTA-octreotide, PET/CT, PET/MR
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

    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/MRDevice

    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.

Study groups in NCT04552847
Study groupRoleWhat they receive
PatientsExperimentalIn 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.
Receives: Drug: Al18F-NOTA-octreotide; Device: PET/CT; Device: PET/MR

What is being measured

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

  1. Differential detection ratio (DDR)

    The fraction of lesions detected by one tracer is the detection ratio. In case of non-inferiority, the difference in detection ratio on Al18F-NOTA-octerotide PET and the detection ratio on 68Ga-DOTA-SSA PET, i.e. the differential detection ratio (DDR), equals zero. The primary objective will be met if the lower margin of the 95% confidence interval for the DDR is higher than -15%. Readers will be blinded for the radiopharmaceutical that is used. (only for part A of the trial)

    Measured: 2 years

Secondary outcomes (11)

  1. Lesion detection rate on the organ level

    A sub analysis will be performed, involving a lesion count per organ to determine the sensitivity of Al18F-NOTA-octreotide PET and 68Ga-DOTA-SSA PET on the organ level.

    Measured: 2 years

  2. Lesion uptake

    Standardized uptake value (SUV) measurements will be performed: SUVmax for lesions and SUVmean for several background areas will be determined. Lesion uptake, in terms of SUVmax and tumor-to-background ratio (TBR), will be compared for both tracers.

    Measured: 2 years

  3. Clinical impact on TNM staging or patient management

    We will evaluate whether different findings with both tracers have a clinical impact, e.g. leading to different TNM staging or differences in patient management. (only part A of the trial as this will be blinded)

    Measured: 2.5 years

  4. Lesion detection rate according to the specific 68Ga-DOTA-SSA used for the routine PET scan

    Due to the multicenter nature of this study, two or three different standard PET tracers will be used for the routine clinical care 68Ga-DOTA-SSA PET: 68Ga-DOTATATE (current standard in UZ Leuven), 68Ga-DOTANOC (current standard in UZ Antwerp), and potentially 68Ga-DOTATOC (depending where patients from UZ Ghent are scanned). Therefore, the diagnostic performance of Al18F-NOTA-octreotide PET will also be compared with the two or three 68Ga-DOTA-SSAs tracers separately.

    Measured: 2 years

  5. Lesion detection rate according to tumor grade

    A sub analysis will be performed, comparing the diagnostic performance and lesion uptake with Al18F-NOTA-octreotide and 68Ga-DOTA-SSA between low-grade and high-grade NETs.

    Measured: 2 years

  6. Overall diagnostic image quality according to a five-point Likert-scale

    As part of an inter-observer agreement analysis, readers will score overall diagnostic image quality using a five-point Likert-scale: (1) non diagnostic, (2) poor, (3) sufficient, (4) good and (5) excellent.

    Measured: 3 years

  7. Lesion conspicuity according to a five-point Likert-scale

    As part of an inter-observer agreement analysis, readers will score lesion conspicuity relative to the surrounding background using a five-point Likert-scale: (1) no increased uptake (equal or lower than background uptake), (2) barely perceived (slightly higher than background uptake), (3) moderately detectable (higher than background uptake, but less than twice, or less than 5 standardized uptake value (SUV) units above, the background uptake), (4) definitely detected (at least twice the background uptake and at least 5 SUV units higher than background uptake) and (5) strikingly evident/easily spotted (evident on maximum intensity projection images and typically higher than uptake in all normal organs, including the spleen).

    Measured: 3 years

  8. Diagnostic confidence according to a five-point Likert-scale

    As part of an inter-observer agreement analysis, for each focus of increased non-physiologic uptake readers will score diagnostic confidence using a five-point Likert-scale: (1) definitely no lesion, (2) probably no lesion, (3) indeterminate, (4) probably a lesion, (5) definitely a lesion.

    Measured: 3 years

  9. Whole-body MRI correlate of the lesions detected by the PET scans

    For the union of lesions identified on both PET scans, MRI images will be checked for corresponding MRI lesions. If a correlating lesion is detected and deemed to be of malignant nature by an experienced whole-body MRI radiologist, the PET lesions will be considered true positives. (only part B of the trial)

    Measured: 2.5 years

  10. Effect of Al18F-NOTA-octreotide injection on blood pressure

    The impact of Al18F-NOTA-octreotide administration on blood pressure (in mmHg) will be assessed. This parameter and changes from baseline values will be scored according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03

    Measured: 2 years

  11. Effect of Al18F-NOTA-octreotide injection on heart rate

    The impact of Al18F-NOTA-octreotide administration on heart rate (in beats per minute) will be assessed. This parameter and changes from baseline values will be scored according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03

    Measured: 2 years

Timeline

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

  1. First posted17 Sep 2020
  2. Study start7 Oct 2020
  3. Primary completion8 Feb 2022
  4. Study completion8 Feb 2022

Resources

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 2/3
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04552847
Sponsor's protocol ID
S63678
Status last verified
Feb 2022
First submitted
3 Sep 2020
Last updated
17 Feb 2022
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

  • Leupe H, Pauwels E, Vandamme T, Van den Broeck B, Lybaert W, Dekervel J, Van Herpe F, Jaekers J, Cleeren F, Hofland J, Brouwers A, Koole M, Bormans G, Van Cutsem E, Geboes K, Laenen A, Verslype C, Stroobants S, Deroose CM. Clinical impact of using [18F]AlF-NOTA-octreotide PET/CT instead of [68Ga]Ga-DOTA-SSA PET/CT: Secondary endpoint analysis of a multicenter, prospective trial. J Neuroendocrinol. 2024 Aug;36(8):e13420. doi: 10.1111/jne.13420. Epub 2024 Jun 4.

    PubMed 38837825

  • Boeckxstaens L, Pauwels E, Vandecaveye V, Deckers W, Cleeren F, Dekervel J, Vandamme T, Serdons K, Koole M, Bormans G, Laenen A, Clement PM, Geboes K, Van Cutsem E, Nackaerts K, Stroobants S, Verslype C, Van Laere K, Deroose CM. Prospective comparison of [18F]AlF-NOTA-octreotide PET/MRI to [68Ga]Ga-DOTATATE PET/CT in neuroendocrine tumor patients. EJNMMI Res. 2023 Jun 1;13(1):53. doi: 10.1186/s13550-023-01003-3.

    PubMed 37261615

  • Pauwels E, Cleeren F, Tshibangu T, Koole M, Serdons K, Boeckxstaens L, Dekervel J, Vandamme T, Lybaert W, den Broeck BV, Laenen A, Clement PM, Geboes K, Cutsem EV, Stroobants S, Verslype C, Bormans G, Deroose CM. 18F-AlF-NOTA-Octreotide Outperforms 68Ga-DOTATATE/NOC PET in Neuroendocrine Tumor Patients: Results from a Prospective, Multicenter Study. J Nucl Med. 2023 Apr;64(4):632-638. doi: 10.2967/jnumed.122.264563. Epub 2022 Oct 20.

    PubMed 36265911

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Al18F-NOTA-octreotide, PET/CT and PET/MR 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 6 inclusion and 14 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 17 Feb 2022. 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Differential detection ratio (DDR) (time frame: 2 years). 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 NCT04552847, which also lists 4 linked publications.

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 17 Feb 2022; AzTrials last refreshed its copy on 7 Nov 2026.

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