Neuroendocrine Carcinoma of PancreasEarly Phase 1NCT03623984
Molecular-Guided Surgery for Pancreatic and GI Neuroendocrine Cancers
A Early Phase 1 study testing Gallium Dotatate in people with Neuroendocrine Carcinoma of Pancreas and Carcinoid, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this study is to see if the use of 68Gallium- positron emission tomography and computer tomography (PET/CT) scans along with NETSPOT® (Advanced Accelerator Applications USA, Inc.) can better define the localization of Neuroendocrine tumors enhancing the surgical removal of Neuroendocrine tumors (NETs). Read more about this study
- Who is it for?
- Ages 19 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuroendocrine Carcinoma of Pancreas, Carcinoid
- What is being tested?
- Gallium Dotatate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2019to 7 Jun 2023
- Phase
- Early Phase 1
- 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 19 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 19 years of age and older
- Male or female patient with a suspected diagnosis of a gastrointestinal-pancreatic neuroendocrine tumor (localized or metastatic) to undergo surgery for resection
- Localization of the tumor with a pre-operative 68Gallium-DOTATATE scan
- In the Investigator's judgement, participant is mentally competent to provide informed consent to participate in the study.
- ECOG performance status of 0-1
- Negative urine pregnancy test at screening, if applicable.
Who cannot join
- Participants who are pregnant, lactating, or intending to become pregnant during the study
- Female participants of child-bearing age who refuse a urine pregnancy test
- Participants who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.
- Participants who have participated in an investigational surgical, drug, or device study within the past 30 days.
- Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
- Patients whose tumors do not localize on a 68Gallium-DOTATATE scan
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Molecular-Guided Surgery for Pancreatic and Gastrointestinal Neuroendocrine Cancers
The purpose of this study is to see if the use of 68Gallium- positron emission tomography and computer tomography (PET/CT) scans along with NETSPOT® (Advanced Accelerator Applications USA, Inc.) can better define the localization of Neuroendocrine tumors enhancing the surgical removal of Neuroendocrine tumors (NETs).
Read the detailed description
A challenge during cancer surgery is determining all sites of malignant disease. Accurate tumor localization is of utmost importance as complete resection increases the chance of cure and improves patient outcomes even when cure is not possible. However, finding the primary tumor can be very challenging and, in some cases, impossible. With the recent FDA approval of a PET tracer (Ga-68 DOTATATE) that binds to somatostatin receptors for imaging neuroendocrine tumors (NETs), the investigator's institution has the opportunity to dramatically improve the surgical care for these patients. Therefore, the aim for this study is to develop a molecular image-guided surgery program starting with GI NETs. GI NETs are malignant neoplasms that are increasing in prevalence. NETs cause a variety of debilitating symptoms, and, as a result, contribute substantially to cancer-related morbidity. Since the primary treatment for NET is surgical resection, NETs are an ideal model to launch a comprehensive image-guided surgery program. Many NETs are metastatic at presentation or will develop metastases during their course, and it is difficult to identify all disease visually and through manual palpation. Failure to surgically resect all disease leads to symptoms, metastatic disease, and multiple surgical interventions. Many institutions have recently begun using Ga-68 DOTATATE for PET/CT imaging of NETs, and this same tracer can be used for intra-operative localization of primary NETs as well as metastases. The primary impediment to using Ga-68 DOTATATE for this purpose is the need to develop and validate a high-energy gamma (HEG) probe for detecting NETs during surgery. This study will explore the new PET tracer technology and begin a molecular image-guided surgery program for NETs. This initial paradigm will be used to develop a molecular image guided approach to other cancers. It is expected that this type of program could usher a new era of cancer management at the investigator's institution at its forefront and improve outcomes for study participants.
- Conditions
- Neuroendocrine Carcinoma of Pancreas, Carcinoid
- Being tested
- Gallium Dotatate
- Keywords
- Gallium-DOTATATE (68), Neuroendocrine Tumors, Pancreatic neuroendocrine Tumors, Molecular, Surgery, Carcinoid
- Medical subject headings
- Carcinoid Tumor, Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gallium DotatateDrug
Also called Gallium-DOTATATE (68)
Radioguided Surgery for Pancreatic- Neuroendocrine Cancers
| Study group | Role | What they receive |
|---|---|---|
| Gallium Dotatate | Experimental | All patients in the study will be undergoing both a 68Gallium-DOTATATE scan for tumor localization and planned surgical resection. Both of these maneuvers are clinically indicated and the standard of care in the care of these patients. Following induction of general endotracheal anesthesia (as required for the surgery portion of treatment), the patients will receive an additional injection of 68Gallium-DOTATATE in the operating room itself. A probe that can detect 68Gallium will be used to identify tumors in the OR within the patient's abdominal cavity for targeted resection. Receives: Drug: Gallium Dotatate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of intraoperative findings to preoperative PET scan findings
PET probes will be used to quantify the level of gallium dotatate in the tumor tissue and be compared to the gallium dotatate uptake of the preoperative PET scan.
Measured: From initial PET scan (2-3 weeks) until completion of the surgery
Secondary outcomes (1)
Determine threshold levels of gallium dotatate uptake in order to determine tumor involvement
Using a high energy PET probe the level of gallium uptake will be compared to histopathology analysis of removed specimen
Measured: From baseline through 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start7 Jun 2019
- Primary completion7 Jun 2022
- Study completion7 Jun 2023 (estimated)
Why it stopped: no partipants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine Carcinoma of PancreasStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sushanth Reddy, University of Alabama at Birmingham
- Investigators
- Sushanth Reddy, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03623984
- Sponsor's protocol ID
- IRB-300001980
- Status last verified
- Sep 2023
- First submitted
- 7 Aug 2018
- Last updated
- 11 Sep 2023
- 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 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular-Guided Surgery for Pancreatic and Gastrointestinal Neuroendocrine Cancers
- ClinicalTrials.gov ID
- NCT03623984
- Acronym / sponsor ID
- IRB-300001980
- Conditions
- Neuroendocrine Carcinoma of Pancreas, Carcinoid
- Keywords
- Gallium-DOTATATE (68), Neuroendocrine Tumors, Pancreatic neuroendocrine Tumors, Molecular, Surgery, Carcinoid
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no partipants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 7 Jun 2019 (actual)
- Primary completion
- 7 Jun 2022 (actual)
- Study completion
- 7 Jun 2023 (estimated)
- First posted
- 9 Aug 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 purpose of this study is to see if the use of 68Gallium- positron emission tomography and computer tomography (PET/CT) scans along with NETSPOT® (Advanced Accelerator Applications USA, Inc.) can better define the localization of Neuroendocrine tumors enhancing the surgical removal of Neuroendocrine tumors (NETs).
Detailed description
A challenge during cancer surgery is determining all sites of malignant disease. Accurate tumor localization is of utmost importance as complete resection increases the chance of cure and improves patient outcomes even when cure is not possible. However, finding the primary tumor can be very challenging and, in some cases, impossible. With the recent FDA approval of a PET tracer (Ga-68 DOTATATE) that binds to somatostatin receptors for imaging neuroendocrine tumors (NETs), the investigator's institution has the opportunity to dramatically improve the surgical care for these patients. Therefore, the aim for this study is to develop a molecular image-guided surgery program starting with GI NETs. GI NETs are malignant neoplasms that are increasing in prevalence. NETs cause a variety of debilitating symptoms, and, as a result, contribute substantially to cancer-related morbidity. Since the primary treatment for NET is surgical resection, NETs are an ideal model to launch a comprehensive image-guided surgery program. Many NETs are metastatic at presentation or will develop metastases during their course, and it is difficult to identify all disease visually and through manual palpation. Failure to surgically resect all disease leads to symptoms, metastatic disease, and multiple surgical interventions. Many institutions have recently begun using Ga-68 DOTATATE for PET/CT imaging of NETs, and this same tracer can be used for intra-operative localization of primary NETs as well as metastases. The primary impediment to using Ga-68 DOTATATE for this purpose is the need to develop and validate a high-energy gamma (HEG) probe for detecting NETs during surgery. This study will explore the new PET tracer technology and begin a molecular image-guided surgery program for NETs. This initial paradigm will be used to develop a molecular image guided approach to other cancers. It is expected that this type of program could usher a new era of cancer management at the investigator's institution at its forefront and improve outcomes for study participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gallium Dotatate | Experimental | Drug: Gallium DotatateAll patients in the study will be undergoing both a 68Gallium-DOTATATE scan for tumor localization and planned surgical resection. Both of these maneuvers are clinically indicated and the standard of care in the care of these patients. Following induction of general endotracheal anesthesia (as required for the surgery portion of treatment), the patients will receive an additional injection of 68Gallium-DOTATATE in the operating room itself. A probe that can detect 68Gallium will be used to identify tumors in the OR within the patient's abdominal cavity for targeted resection. |
Who may qualify
- Ages
- 19 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- At least 19 years of age and older
- Male or female patient with a suspected diagnosis of a gastrointestinal-pancreatic neuroendocrine tumor (localized or metastatic) to undergo surgery for resection
- Localization of the tumor with a pre-operative 68Gallium-DOTATATE scan
- In the Investigator's judgement, participant is mentally competent to provide informed consent to participate in the study.
- ECOG performance status of 0-1
Key exclusion criteria (6 listed)
- Participants who are pregnant, lactating, or intending to become pregnant during the study
- Female participants of child-bearing age who refuse a urine pregnancy test
- Participants who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.
- Participants who have participated in an investigational surgical, drug, or device study within the past 30 days.
- Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
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 |
|---|---|---|
| Gallium DotatateAlso: Gallium-DOTATATE (68)Radioguided Surgery for Pancreatic- Neuroendocrine Cancers | Drug | Gallium Dotatate |
Primary outcome
Comparison of intraoperative findings to preoperative PET scan findings
Time frame: From initial PET scan (2-3 weeks) until completion of the surgery
PET probes will be used to quantify the level of gallium dotatate in the tumor tissue and be compared to the gallium dotatate uptake of the preoperative PET scan.
1 secondary outcome
Determine threshold levels of gallium dotatate uptake in order to determine tumor involvement
Time frame: From baseline through 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
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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.
Sushanth Reddy, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Gallium Dotatate in people with Neuroendocrine Carcinoma of Pancreas and Carcinoid, run by University of Alabama at Birmingham 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 6 inclusion and 6 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: withdrawn, as of the sponsor's last update on 11 Sep 2023. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Comparison of intraoperative findings to preoperative PET scan findings (time frame: From initial PET scan (2-3 weeks) until completion of the surgery). 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 11 Sep 2023.