Al18F-NOTA-octreotide PET Imaging in Neuroendocrine Tumors

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04552847
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2/Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Universitaire Ziekenhuizen Leuven
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Christophe Deroose, MD, PhD
Principal Investigator Affiliation Universitaire Ziekenhuizen Leuven
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Belgium
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Neuroendocrine Tumors
Additional Details

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.

Arms & Interventions

Arms

Experimental: 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.

Interventions

Drug: - Al18F-NOTA-octreotide

One intravenous injection of 4 MBq/kg

Device: - 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.

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Universitaire Ziekenhuizen Leuven, Leuven, Belgium

Status

Recruiting

Address

Universitaire Ziekenhuizen Leuven

Leuven, , 3000

Site Contact

Christophe Deroose, MD, PhD

christophe.deroose@uzleuven.be

+32 16 343715

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