Neuroendocrine NeoplasmPhase 1/2NCT03511768
A Study of 18F-AlF-NOTA-octreotide PET/CT for Imaging Neuroendocrine Neoplasms
A Phase 1/2 study testing 18F-AlF-NOTA-octreotide and PET/CT in people with Neuroendocrine Neoplasm, run by Xiangya Hospital of Central South University at 1 site in China.
Trial summary
The aim of this study is to investigate the clinical value of [18F]aluminum fluoride-1,4,7-triazacyclononane-1,4,7-triacetic acid-octreotide（18F-AlF-NOTA-octreotide ） positron emission tomography / computed tomography (PET/CT) in patients with neuroendocrine neoplasms (NENs). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neuroendocrine Neoplasm
- What is being tested?
- 18F-AlF-NOTA-octreotide and PET/CT
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteChina
- Study dates
- 2 Jan 2018to 30 Dec 2020
- Phase
- Phase 1/2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Histologically and/or clinically confirmed and/or suspicious of NEN.
- Signed informed consent.
Who cannot join
- Claustrophobia (unable to accept PET/CT scanning)
- Pregnant or breast-feeding
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of PET Center,Xiangya Hospital,Central South University
Changsha, Hunan, 410008
Tingting Long, MD,Phd, +86 13549682646, longtingting@csu.edu.cn
About this study
The aim of this study is to investigate the clinical value of [18F]aluminum fluoride-1,4,7-triazacyclononane-1,4,7-triacetic acid-octreotide（18F-AlF-NOTA-octreotide ） positron emission tomography / computed tomography (PET/CT) in patients with neuroendocrine neoplasms (NENs).
Read the detailed description
18F-AlF-NOTA-octreotide is a radioligand targeting the somatostatin receptor, which is widely expressed on the cell surface of NENs. The radioligand can be used for the diagnosis and stage of the NENs. A total of 5 volunteers and 60 NEN patients will be subjected to a 18F-AlF-NOTA-octreotide PET/CT scan. The uptake of 18F-AlF-NOTA-octreotide in organs and tumor lesions will be quantified as Standardized Uptake Values (SUVmax/SUVmean).
- Conditions
- Neuroendocrine Neoplasm
- Being tested
- 18F-AlF-NOTA-octreotide, PET/CT
- Keywords
- 18F-AlF-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.
18F-AlF-NOTA-octreotideDrug
Also called 18F-IMP466
One injection of 18F-AlF-NOTA-octreotide
PET/CTDevice
Following injection of 18F-AlF-NOTA-octreotide the participants will be subjected to whole body PET/CT
| Study group | Role | What they receive |
|---|---|---|
| 18F-AlF-NOTA-octreotide PET/CT | Experimental | One injection of the radioligand 18F-AlF-NOTA-octreotide Receives: Drug: 18F-AlF-NOTA-octreotide; Device: PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
18F-AlF-NOTA-octreotide PET/CT imaging of patients with Neuroendocrine Neoplasms
The radioligand 18F-AlF-NOTA-octreotide can be used to visualize neuroendocrine neoplasms
Measured: 12 months
Secondary outcomes (1)
18F-AlF-NOTA-octreotide PET/CT prognostic factor for overall and disease specific survival
The uptake of the 18F-AlF-NOTA-octreotide in neuroendocrine neoplasm lesions (quantified as Standard Uptake Values) is associated with overall and disease specific free survival (PFS) neuroendocrine neoplasms
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2018
- Study start2 Jan 2018
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Dec 2020 (estimated)
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 NeoplasmStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe 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 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tingting Long, MD,Phd, Principal investigator, Department of PET Center,Xiangya Hospital, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03511768
- Sponsor's protocol ID
- 201801001
- Status last verified
- Apr 2018
- First submitted
- 17 Apr 2018
- Last updated
- 30 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Laverman P, McBride WJ, Sharkey RM, Eek A, Joosten L, Oyen WJ, Goldenberg DM, Boerman OC. A novel facile method of labeling octreotide with (18)F-fluorine. J Nucl Med. 2010 Mar;51(3):454-61. doi: 10.2967/jnumed.109.066902. Epub 2010 Feb 11.
PubMed 20150268
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of 18F-AlF-NOTA-octreotide PET/CT for Imaging Neuroendocrine Neoplasms
- ClinicalTrials.gov ID
- NCT03511768
- Acronym / sponsor ID
- 201801001
- Conditions
- Neuroendocrine Neoplasm
- Keywords
- 18F-AlF-NOTA-octreotide
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 30 Apr 2018 (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.
The aim of this study is to investigate the clinical value of [18F]aluminum fluoride-1,4,7-triazacyclononane-1,4,7-triacetic acid-octreotide（18F-AlF-NOTA-octreotide ） positron emission tomography / computed tomography (PET/CT) in patients with neuroendocrine neoplasms (NENs).
Detailed description
18F-AlF-NOTA-octreotide is a radioligand targeting the somatostatin receptor, which is widely expressed on the cell surface of NENs. The radioligand can be used for the diagnosis and stage of the NENs. A total of 5 volunteers and 60 NEN patients will be subjected to a 18F-AlF-NOTA-octreotide PET/CT scan. The uptake of 18F-AlF-NOTA-octreotide in organs and tumor lesions will be quantified as Standardized Uptake Values (SUVmax/SUVmean).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-AlF-NOTA-octreotide PET/CT | Experimental | Drug: 18F-AlF-NOTA-octreotide, Device: PET/CTOne injection of the radioligand 18F-AlF-NOTA-octreotide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Histologically and/or clinically confirmed and/or suspicious of NEN.
- Signed informed consent.
Key exclusion criteria (2 listed)
- Claustrophobia (unable to accept PET/CT scanning)
- Pregnant or breast-feeding
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 |
|---|---|---|
| 18F-AlF-NOTA-octreotideAlso: 18F-IMP466One injection of 18F-AlF-NOTA-octreotide | Drug | 18F-AlF-NOTA-octreotide PET/CT |
| PET/CTFollowing injection of 18F-AlF-NOTA-octreotide the participants will be subjected to whole body PET/CT | Device | 18F-AlF-NOTA-octreotide PET/CT |
Primary outcome
18F-AlF-NOTA-octreotide PET/CT imaging of patients with Neuroendocrine Neoplasms
Time frame: 12 months
The radioligand 18F-AlF-NOTA-octreotide can be used to visualize neuroendocrine neoplasms
1 secondary outcome
18F-AlF-NOTA-octreotide PET/CT prognostic factor for overall and disease specific survival
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2018.
- Results publication: PubMed 20150268Laverman P, McBride WJ, Sharkey RM, Eek A, Joosten L, Oyen WJ, Goldenberg DM, Boerman OC. A novel facile method of labeling octreotide with (18)F-fluorine. J Nucl Med. 2010 Mar;51(3):454-61. doi: 10.2967/jnumed.109.066902. Epub 2010 Feb 11.
- Individual participant dataSharing planned: No
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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.
Tingting Long, MD,Phd principal investigator
Department of PET Center,Xiangya Hospital, Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 18F-AlF-NOTA-octreotide and PET/CT in people with Neuroendocrine Neoplasm, run by Xiangya Hospital of Central South University at 1 site in China.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 30 Apr 2018. 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 China. 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 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tingting Long, MD,Phd (+86 13549682646, longtingting@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
18F-AlF-NOTA-octreotide PET/CT imaging of patients with Neuroendocrine Neoplasms (time frame: 12 months). 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 NCT03511768, 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 30 Apr 2018; AzTrials last refreshed its copy on 7 Nov 2026.