Gastroenteropancreatic Neuroendocrine TumorsNCT07898904
Incremental Value of Delayed 68Ga-DOTATATE PET/MR in the Detection of Liver Metastases
An observational study of Gastroenteropancreatic Neuroendocrine Tumors, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
Trial summary
68-Ga-DOTATATE is a radiotracer targeting somatostatin receptors (SSTR). In this study, we investigated the diagnostic efficacy of delayed ^68^Ga-DOTATATE PET/MR in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs) and liver metastases, and performed a head-to-head comparison with conventional… Read more about this study
- Who is it for?
- Ages 30 to 74 years
- Conditions the study is for
- Gastroenteropancreatic Neuroendocrine Tumors
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 30 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 30 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 46 patients (18 males and 28 females; 56.4±12.9 years（30-74 years old）)
Who may be able to join
- (a)Histologically confirmed well-differentiated GEP-NETs via biopsy or surgical resection in adults aged 18-80 years,(b) confirmed or suspected liver metastases, as determined by previous imaging studies or PET/CT scans,(c) availability of comprehensive surgical reports, pathological findings, comparative data, and clinical follow-up outcomes for analysis,(d) absence of PET/MR contraindications , with voluntary participation and signed informed consent forms adhering to ethical and research guidelines
Who cannot join
- unavailability of surgical, pathological or long-term follow-up data; (b) non-compliance with age eligibility criteria or presence of comorbidities compromising protocol adherence
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Nuclear Medicine, the First Affiliated Hospital, Fujian Medical University
Fuzhou, Fujian, 350000
Weibing Miao, 0591-87981619, linzefang1993@163.com
About this study
Official title: Incremental Value of Delayed 68Ga-DOTATATE PET/MR in the Detection of Liver Metastases From Gastroenteropancreatic Neuroendocrine Tumors
68-Ga-DOTATATE is a radiotracer targeting somatostatin receptors (SSTR). In this study, we investigated the diagnostic efficacy of delayed ^68^Ga-DOTATATE PET/MR in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs) and liver metastases, and performed a head-to-head comparison with conventional 68-Ga-DOTATATE PET/CT.
Read the detailed description
68-Ga-DOTATATE PET/CT has been established as a gold standard for the diagnosis and staging of well-differentiated gastroenteropancreatic neuroendocrine tumors (GEP-NETs). However, its limitations in detecting small or low-avidity liver metastases remain a clinical challenge. In this study, we further evaluate the diagnostic performance of delayed ^68^Ga-DOTATATE positron emission tomography/magnetic resonance (PET/MR) in patients with GEP-NETs and suspected liver metastases, with a direct comparison to conventional 68-Ga-DOTATATE PET/CT.
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Sensitivity of Delayed ^68^Ga-DOTATATE PET/MR in Detecting Liver Metastases from GEP-NETs Relative to Conventional Imaging
Using contrast-enhanced MRI or CT as the reference standard, validate the true positive detection rate of delayed ^68^Ga-DOTATATE PET/MR for liver metastases in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Two experienced readers, blinded to the clinical history but not to the imaging modality, independently assessed the PET/MR and PET/CT images. Disagreements were resolved by consensus.
Measured: Conventional imaging (MRI or CT) was performed within 3 months of the PET studies.
2. Lesion Detection Rate of Delayed ^68^Ga-DOTATATE PET/MR Compared to Conventional PET/CT in Patients with GEP-NETs
Using a composite reference standard including conventional imaging (MRI/CT) and consensus reading, compare the number and characteristics of liver metastases detected by delayed PET/MR versus conventional PET/CT. Two accredited readers evaluated the images in separate sessions. Additional lesions identified only on PET/MR were categorized as high-uptake or non-uptake based on ^68^Ga-DOTATATE avidity.
Measured: All PET/CT and PET/MR scans were performed on the same day following a single radiotracer injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start1 Dec 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroenteropancreatic Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Fujian Medical 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Weibing Miao, MD, Study chair, First Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07898904
- Sponsor's protocol ID
- FirstAHFujian-Delayed PET/MR
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incremental Value of Delayed 68Ga-DOTATATE PET/MR in the Detection of Liver Metastases From Gastroenteropancreatic Neuroendocrine Tumors
- ClinicalTrials.gov ID
- NCT07898904
- Acronym / sponsor ID
- FirstAHFujian-Delayed PET/MR
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 27 Oct 2026 (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.
68-Ga-DOTATATE is a radiotracer targeting somatostatin receptors (SSTR). In this study, we investigated the diagnostic efficacy of delayed ^68^Ga-DOTATATE PET/MR in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs) and liver metastases, and performed a head-to-head comparison with conventional 68-Ga-DOTATATE PET/CT.
Detailed description
68-Ga-DOTATATE PET/CT has been established as a gold standard for the diagnosis and staging of well-differentiated gastroenteropancreatic neuroendocrine tumors (GEP-NETs). However, its limitations in detecting small or low-avidity liver metastases remain a clinical challenge. In this study, we further evaluate the diagnostic performance of delayed ^68^Ga-DOTATATE positron emission tomography/magnetic resonance (PET/MR) in patients with GEP-NETs and suspected liver metastases, with a direct comparison to conventional 68-Ga-DOTATATE PET/CT.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 30 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 46 patients (18 males and 28 females; 56.4±12.9 years（30-74 years old）)
Key inclusion criteria (1 listed)
- (a)Histologically confirmed well-differentiated GEP-NETs via biopsy or surgical resection in adults aged 18-80 years,(b) confirmed or suspected liver metastases, as determined by previous imaging studies or PET/CT scans,(c) availability of comprehensive surgical reports, pathological findings, comparative data, and clinical follow-up outcomes for analysis,(d) absence of PET/MR contraindications , with voluntary participation and signed informed consent forms adhering to ethical and research guidelines
Key exclusion criteria (1 listed)
- unavailability of surgical, pathological or long-term follow-up data; (b) non-compliance with age eligibility criteria or presence of comorbidities compromising protocol adherence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
1. Sensitivity of Delayed ^68^Ga-DOTATATE PET/MR in Detecting Liver Metastases from GEP-NETs Relative to Conventional Imaging
Time frame: Conventional imaging (MRI or CT) was performed within 3 months of the PET studies.
Using contrast-enhanced MRI or CT as the reference standard, validate the true positive detection rate of delayed ^68^Ga-DOTATATE PET/MR for liver metastases in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Two experienced readers, blinded to the clinical history but not to the imaging modality, independently assessed the PET/MR and PET/CT images. Disagreements were resolved by consensus.
2. Lesion Detection Rate of Delayed ^68^Ga-DOTATATE PET/MR Compared to Conventional PET/CT in Patients with GEP-NETs
Time frame: All PET/CT and PET/MR scans were performed on the same day following a single radiotracer injection.
Using a composite reference standard including conventional imaging (MRI/CT) and consensus reading, compare the number and characteristics of liver metastases detected by delayed PET/MR versus conventional PET/CT. Two accredited readers evaluated the images in separate sessions. Additional lesions identified only on PET/MR were categorized as high-uptake or non-uptake based on ^68^Ga-DOTATATE avidity.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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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.
Weibing Miao, MD study chair
First Affiliated Hospital of Fujian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroenteropancreatic Neuroendocrine Tumors, run by First Affiliated Hospital of Fujian Medical 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 27 Oct 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weibing Miao, MD (86-0591-87981618, miaoweibing@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Sensitivity of Delayed ^68^Ga-DOTATATE PET/MR in Detecting Liver Metastases from GEP-NETs Relative to Conventional Imaging (time frame: Conventional imaging (MRI or CT) was performed within 3 months of the PET studies.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2026.