Neuroendocrine CarcinomaNCT04069299
Use of 68Ga-dotatate PET Scan in Neuroendocrine Carcinoma of the GI Tract
An observational study of Neuroendocrine Carcinoma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The purpose of the study is to understand the extent and degree of somatostatin receptor expression in poorly differentiated neuroendocrine carcinomas . This may help to make a determination if a radiolabeled somatostatin analog therapy, also referred to as peptide receptor radiotherapy (PRRT), can be a potential… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Carcinoma
- What is being tested?
- 68Ga-DOTATATE and Positron Emission Tomography (PET) Scan
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2019to 2 Jun 2025
- Phase
- Observational
- 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
Study population: Patients of Moffitt Cancer Center's GI Clinic
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female ≥ 18 years old
- Histologically confirmed diagnosis of poorly-differentiated neuroendocrine carcinoma of the gastroenteropancreatic tract or unknown primary
- Evidence of measurable disease per RECIST 1.1 on another imagine modality (CT, MRI or FDGPET) with at least 3 tumors >1cm in largest diameter. CT, MRI or Fluorodeoxyglucose (FDG)-PET must have been performed within 2 months of the study scan. (Of note, participants may sign consent for the study prior to scheduling of said CT, MRI or FDG-PET, but will be considered screen failures if the CT/MRI/FDG-PET does not reveal at least 3 tumors >1cm).
Who cannot join
- Participants with well-differentiated neuroendocrine tumors
- Participants who have undergone 68Ga-dotatate PET scan in the past
- Pregnant women and/or breastfeeding women. Women of child bearing potential must have a negative pregnancy test prior to scan.
Trial locations and contacts
1 site in 1 country.
United States1 site
H Lee Moffitt Cancer & Research Institute
Tampa, Florida, 33612
About this study
Official title: Somatostatin Receptor Expression in Poorly-Differentiated Neuroendocrine Carcinomas of the GI Tract: Analysis Using 68Ga-dotatate PET Scan
The purpose of the study is to understand the extent and degree of somatostatin receptor expression in poorly differentiated neuroendocrine carcinomas . This may help to make a determination if a radiolabeled somatostatin analog therapy, also referred to as peptide receptor radiotherapy (PRRT), can be a potential alternative in the future. At this time, radiolabeled somatostatin analogs have not been tested in patients with poorly differentiated neuroendocrine carcinomas, and their efficacy in this disease is not well known Understanding the extent and degree of somatostatin receptor expression is important in order to evaluate the potential of radiolabeled somatostatin analog therapy for treatment of poorly differentiated neuroendocrine carcinomas.
- Conditions
- Neuroendocrine Carcinoma
- Being tested
- 68Ga-DOTATATE, Positron Emission Tomography (PET) Scan
- Medical subject headings
- Carcinoma, Neuroendocrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-DOTATATEDrug
Also called NETspot
The NETspot kit is 2 vials, Vial 1 contains 40 mcg dotatate, 5 mcg 1,10phenanthroline; 6mcg gentisic acid and 20 mg mannitol. Vial 2 contains 60 mg formic acid, 56.5 mg sodium hydroxide and water for injection
Positron Emission Tomography (PET) ScanDiagnostic test
PET scan is an imaging test using radioactive tracers.
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving PET scan | Participants with metastatic poorly-differentiated neuroendocrine carcinomas of the GI tract Receives: Drug: 68Ga-DOTATATE; Diagnostic Test: Positron Emission Tomography (PET) Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Uniformly Positive 68Ga-dotatate PET
Percentage of participants with uniformly positive 68Ga-dotatate PET (positivity defined as SUV uptake > liver for all tumors at least 1cm in size). Note: Standard Uptake Value (SUV) is used to determine activity in PET imaging.
Measured: Up to 10 months
Secondary outcomes (1)
Percentage of Participants with No Uptake to Very High Uptake on PET
Percentage of Participants with no uptake, heterogeneous uptake (tumors showing substantial differences in Somatostatin receptor [SSTR] uptake), low uptake (max SUV≤ liver), moderate uptake (liver<max SUV ≤2x liver, high uptake (max SUV > 2x liver), very high uptake (max SUV≥ kidney or spleen). Note: Standard Uptake Value (SUV) is used to determine activity in PET imaging.
Measured: Up to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start25 Sep 2019
- Primary completion2 Jun 2025
- Study completion2 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine CarcinomaStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Advanced Accelerator Applications
- Responsible party
- Sponsor
- Investigators
- Jonathan Strosberg, MD, Principal investigator, H Lee Moffitt Cancer & Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04069299
- Sponsor's protocol ID
- MCC-19943
- Status last verified
- Mar 2026
- First submitted
- 22 Aug 2019
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Somatostatin Receptor Expression in Poorly-Differentiated Neuroendocrine Carcinomas of the GI Tract: Analysis Using 68Ga-dotatate PET Scan
- ClinicalTrials.gov ID
- NCT04069299
- Acronym / sponsor ID
- MCC-19943
- Conditions
- Neuroendocrine Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Advanced Accelerator Applications
- Study start
- 25 Sep 2019 (actual)
- Primary completion
- 2 Jun 2025 (actual)
- Study completion
- 2 Jun 2025 (actual)
- First posted
- 28 Aug 2019 (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 purpose of the study is to understand the extent and degree of somatostatin receptor expression in poorly differentiated neuroendocrine carcinomas . This may help to make a determination if a radiolabeled somatostatin analog therapy, also referred to as peptide receptor radiotherapy (PRRT), can be a potential alternative in the future. At this time, radiolabeled somatostatin analogs have not been tested in patients with poorly differentiated neuroendocrine carcinomas, and their efficacy in this disease is not well known Understanding the extent and degree of somatostatin receptor expression is important in order to evaluate the potential of radiolabeled somatostatin analog therapy for treatment of poorly differentiated neuroendocrine carcinomas.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants receiving PET scan | – | Drug: 68Ga-DOTATATE, Diagnostic Test: Positron Emission Tomography (PET) ScanParticipants with metastatic poorly-differentiated neuroendocrine carcinomas of the GI tract |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of Moffitt Cancer Center's GI Clinic
Key inclusion criteria (5 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female ≥ 18 years old
- Histologically confirmed diagnosis of poorly-differentiated neuroendocrine carcinoma of the gastroenteropancreatic tract or unknown primary
- Evidence of measurable disease per RECIST 1.1 on another imagine modality (CT, MRI or FDGPET) with at least 3 tumors >1cm in largest diameter. CT, MRI or Fluorodeoxyglucose (FDG)-PET must have been performed within 2 months of the study scan. (Of note, participants may sign consent for the study prior to scheduling of said CT, MRI or FDG-PET, but will be considered screen failures if the CT/MRI/FDG-PET does not reveal at least 3 tumors >1cm).
Key exclusion criteria (3 listed)
- Participants with well-differentiated neuroendocrine tumors
- Participants who have undergone 68Ga-dotatate PET scan in the past
- Pregnant women and/or breastfeeding women. Women of child bearing potential must have a negative pregnancy test prior to scan.
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 |
|---|---|---|
| 68Ga-DOTATATEAlso: NETspotThe NETspot kit is 2 vials, Vial 1 contains 40 mcg dotatate, 5 mcg 1,10phenanthroline; 6mcg gentisic acid and 20 mg mannitol. Vial 2 contains 60 mg formic acid, 56.5 mg sodium hydroxide and water for injection | Drug | Participants receiving PET scan |
| Positron Emission Tomography (PET) ScanPET scan is an imaging test using radioactive tracers. | Diagnostic test | Participants receiving PET scan |
Primary outcome
Percentage of Participants with Uniformly Positive 68Ga-dotatate PET
Time frame: Up to 10 months
Percentage of participants with uniformly positive 68Ga-dotatate PET (positivity defined as SUV uptake > liver for all tumors at least 1cm in size). Note: Standard Uptake Value (SUV) is used to determine activity in PET imaging.
1 secondary outcome
Percentage of Participants with No Uptake to Very High Uptake on PET
Time frame: Up to 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 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. This study is not recruiting at the moment.
Jonathan Strosberg, MD principal investigator
H Lee Moffitt Cancer & Research Institute
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 Neuroendocrine Carcinoma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
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 5 inclusion and 3 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 31 Mar 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 United States. 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?
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?
Percentage of Participants with Uniformly Positive 68Ga-dotatate PET (time frame: Up to 10 months). 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 31 Mar 2026.