Neuroendocrine TumorsNCT02609737
Theranostics of Radiolabeled Somatostatin Antagonists 68Ga-DOTA-JR11 and 177Lu-DOTA-JR11 in Patients With Neuroendocrine Tumors
A study testing PET/CT Imaging, 68Ga-DOTA-JR11 and 177Lu-DOTA-JR11 in people with Neuroendocrine Tumors, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
This study has 3 steps and not everyone will have all 3 steps done. The overall goals are to see if a new experimental drug is safe to image (step 1) and treat neuroendocrine tumors (step 2 and 3). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- PET/CT Imaging, 68Ga-DOTA-JR11 and 177Lu-DOTA-JR11
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2015to 10 Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Ability to understand and the willingness to sign a written informed consent document
- Adults ≥ 18 years old
- Histologically or cytologically confirmed metastatic and/or unresectable progressive, well differentiated carcinoid or pancreatic NET carcinoids
- Progressive metastatic disease defined by one of the following, occurring within 6 months of study entry:
- At least a 20% increase in radiologically or clinically measurable disease
- Appearance of any new lesion
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- Symptomatic disease (including worsening hormonal symptoms or symptoms related to tumor burden)
- Measurable disease as defined by RECIST 1.1.
- At least one metastasis must show uptake of 111In-DTPA-octreotide on SPECT that is higher than the physiologic radiotracer uptake by the liver
- ECOG performance status ≤ 2 (Karnofsky ≥ 60%)
- Patients must have normal organ and marrow function as defined below:
- Leukocytes ≥ 3.0 x 109/L
- Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L
- Hemoglobin ≥ 9.0 g/dL
- Platelets ≥ 200 x 10^9/L
- Total bilirubin ≤ 1.25 x Upper Limit Normal (ULN)
- AST (SGOT)/ ALT(SGPT) ≤ 2.5 x ULN with liver metastases
- Alkaline phosphatase < 2 x ULN (if known liver or bone disease)
- Serum albumin > 30 g/L, or serum albumin = 30 g/L but normal prothrombin time
- Creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) calculated CrCl ≥ 60 mL/min/1.73m^2
- Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation
- Previous local therapy (e.g., chemoembolization or bland embolization) is allowed if completed > 6 weeks prior to study entry. For such patients, there must be either progression of measurable disease documented within the treatment field, or measurable progressive disease outside the treatment field prior to study entry.
- Previous chemotherapy and/or investigational agents are allowed if completed > 4 weeks prior to study entry (> 6 weeks if last regimen contained bis-chloroethyl nitrosourea (BCNU) or mitomycin C). For patients who received systemic therapy prior to study entry, there must be documented progression of measurable disease since receiving systemic therapy prior to study entry.
- Patients must not have disease that is currently amenable to surgery. Prior surgery is allowed no less than 6 weeks prior to study entry.
Who cannot join
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to 177Lu-DOTA-JR11 as assessed from medical records
- Life expectancy < 6 months as assessed by the treating physician.
- Treatment with short-acting somatostatin analogs less than 3 days and Sandostatin® depot injection less than 5 weeks before scanning and treatment
- Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Women who are pregnant or breastfeeding
- Toxicities from prior therapies that have not resolved to grade 1 or grade 0
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- Known CNS metastases and/or carcinomatous meningitis
- Active malignancy of metastatic potential other than the known carcinoid or pancreatic NET within the past three years
- >20% bone marrow external beam radiotherapy and/or previous radioisotope therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
This study has 3 steps and not everyone will have all 3 steps done. The overall goals are to see if a new experimental drug is safe to image (step 1) and treat neuroendocrine tumors (step 2 and 3).
- Conditions
- Neuroendocrine Tumors
- Being tested
- PET/CT Imaging, 68Ga-DOTA-JR11, 177Lu-DOTA-JR11
- Keywords
- Radiolabeled Somatostatin Antagonists, 68Ga-DOTA-JR11, 177Lu-DOTA-JR11, Pet scan, CT scan, 15-161
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CT ImagingDevice
68Ga-DOTA-JR11Radiation
177Lu-DOTA-JR11Radiation
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-DOTA-JR11 and 177Lu-DOTA-JR11 | Experimental | Pts get a PET/CT study with approx.150-200 MBq of 68Ga-DOTA-JR11. Lesions with focal radiotracer uptake not explained by physiologic sstr2 expression will be interpreted as metastatic disease. If 68Ga-DOTA-JR11 uptake by metastases with a diameter of more than 2 cm is less than the physiologic radiotracer uptake by the liver, no further imaging \& therapy will be performed as part of the study, as it is unlikely that pts with this low radiotracer uptake will benefit from PRRT (2). All other pts will undergo a dosimetric study with 1850 MBq (less than 100 μg peptide) of 177Lu-DOTA-JR11. Results of the dosimetry study, will determine the balance of activity of 177Lu-DOTA-JR11 that can be administered without exceeding the radiation dose limits. This activity will be split into 2 equal amounts to be delivered in 2 cycles, approximately 3 months apart. After each therapy cycle, pts will be followed clinically for 3 months. Receives: Device: PET/CT Imaging; Radiation: 68Ga-DOTA-JR11; Radiation: 177Lu-DOTA-JR11 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
according to RECIST 1.1 and median progression-free and overall survival will be estimated and reported with 95% confidence intervals
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study start13 Nov 2015
- Primary completion10 Dec 2020
- Study completion10 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa Bodei, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02609737
- Sponsor's protocol ID
- 15-161
- Status last verified
- Dec 2020
- First submitted
- 18 Nov 2015
- Last updated
- 1 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Theranostics of Radiolabeled Somatostatin Antagonists 68Ga-DOTA-JR11 and 177Lu-DOTA-JR11 in Patients With Neuroendocrine Tumors
- ClinicalTrials.gov ID
- NCT02609737
- Acronym / sponsor ID
- 15-161
- Conditions
- Neuroendocrine Tumors
- Keywords
- Radiolabeled Somatostatin Antagonists, 68Ga-DOTA-JR11, 177Lu-DOTA-JR11, Pet scan, CT scan, 15-161
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 13 Nov 2015 (actual)
- Primary completion
- 10 Dec 2020 (actual)
- Study completion
- 10 Dec 2020 (actual)
- First posted
- 20 Nov 2015 (estimated)
- Results
- Posted 1 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study has 3 steps and not everyone will have all 3 steps done. The overall goals are to see if a new experimental drug is safe to image (step 1) and treat neuroendocrine tumors (step 2 and 3).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-DOTA-JR11 and 177Lu-DOTA-JR11 | Experimental | Device: PET/CT Imaging, Radiation: 68Ga-DOTA-JR11, Radiation: 177Lu-DOTA-JR11Pts get a PET/CT study with approx.150-200 MBq of 68Ga-DOTA-JR11. Lesions with focal radiotracer uptake not explained by physiologic sstr2 expression will be interpreted as metastatic disease. If 68Ga-DOTA-JR11 uptake by metastases with a diameter of more than 2 cm is less than the physiologic radiotracer uptake by the liver, no further imaging \& therapy will be performed as part of the study, as it is unlikely that pts with this low radiotracer uptake will benefit from PRRT (2). All other pts will undergo a dosimetric study with 1850 MBq (less than 100 μg peptide) of 177Lu-DOTA-JR11. Results of the dosimetry study, will determine the balance of activity of 177Lu-DOTA-JR11 that can be administered without exceeding the radiation dose limits. This activity will be split into 2 equal amounts to be delivered in 2 cycles, approximately 3 months apart. After each therapy cycle, pts will be followed clinically for 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Ability to understand and the willingness to sign a written informed consent document
- Adults ≥ 18 years old
- Histologically or cytologically confirmed metastatic and/or unresectable progressive, well differentiated carcinoid or pancreatic NET carcinoids
- Progressive metastatic disease defined by one of the following, occurring within 6 months of study entry:
- Measurable disease as defined by RECIST 1.1.
Key exclusion criteria (9 listed)
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to 177Lu-DOTA-JR11 as assessed from medical records
- Life expectancy < 6 months as assessed by the treating physician.
- Treatment with short-acting somatostatin analogs less than 3 days and Sandostatin® depot injection less than 5 weeks before scanning and treatment
- Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Women who are pregnant or breastfeeding
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 |
|---|---|---|
| PET/CT Imaging | Device | 68Ga-DOTA-JR11 and 177Lu-DOTA-JR11 |
| 68Ga-DOTA-JR11 | Radiation | 68Ga-DOTA-JR11 and 177Lu-DOTA-JR11 |
| 177Lu-DOTA-JR11 | Radiation | 68Ga-DOTA-JR11 and 177Lu-DOTA-JR11 |
Primary outcome
Overall Response Rate (ORR)
Time frame: 2 years
according to RECIST 1.1 and median progression-free and overall survival will be estimated and reported with 95% confidence intervals
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Lisa Bodei, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET/CT Imaging, 68Ga-DOTA-JR11 and 177Lu-DOTA-JR11 in people with Neuroendocrine Tumors, run by Memorial Sloan Kettering Cancer Center 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 24 inclusion and 9 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 1 Feb 2022. 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?
Yes. Results are posted in the registry (first posted 1 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Response Rate (ORR) (time frame: 2 years). 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 1 Feb 2022.