Al18F-NOTA-octreotide PET Imaging in Neuroendocrine Tumors

NCT04552847 | Completed Phase 2

• 1 other identifier: S63678
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neuroendocrine Tumors

Keywords

Somatostatin receptor imaging; Al18F-NOTA-octreotide; PET/CT; PET/MR

Outcome Measures

Primary Outcomes (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)

  2 years

Secondary Outcomes (11)

• Lesion detection rate on the organ level

  2 years

• Lesion uptake

  2 years

• Clinical impact on TNM staging or patient management

  2.5 years

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

  2 years

• Lesion detection rate according to tumor grade

  2 years

Study Arms (1)

Patients

EXPERIMENTAL

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.

Drug: Al18F-NOTA-octreotide; Device: PET/CT; Device: PET/MR

Interventions

Al18F-NOTA-octreotide DRUG

One intravenous injection of 4 MBq/kg

Also known as: 18F-AlF-NOTA-octreotide, 18F-IMP-466

Patients

PET/CT 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.

Patients

PET/MR 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.

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• University Hospital, Antwerp: collaborator
• University Hospital, Ghent: collaborator
• NETwerk, Belgium: collaborator

Study Sites (1)

Universitaire Ziekenhuizen Leuven

Leuven, 3000, Belgium

Location

Related Publications (4)

• 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: 32617641 BACKGROUND

• 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.

  PMID: 38837825 DERIVED

• 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.

  PMID: 37261615 DERIVED

• 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.

  PMID: 36265911 DERIVED

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

Al18F-NOTA-octreotide; Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Christophe Deroose, MD, PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: September 17, 2020
• Study Start: October 7, 2020
• Primary Completion: February 8, 2022
• Study Completion: February 8, 2022
• Last Updated: February 17, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)