Trial · NCT03453489
AMT-PET in Monitoring Telotristat Etiprate Treatment in Participants With MetastaticNeuroendocrine Neoplasm
NCT03453489, Phase 2, Completed, Barbara Ann Karmanos Cancer Institute; results first posted 2025-04-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. AMT-PET in Monitoring Telotristat Etiprate Treatment in Participants With MetastaticNeuroendocrine Neoplasm. Trials, record NCT03453489. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03453489
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- AMT-PET in Monitoring Telotristat Etiprate Treatment in Participants With MetastaticNeuroendocrine Neoplasm
- NCT number
- NCT03453489
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 4 participants, actual
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Conditions
- Carcinoid Syndrome, Metastatic Nonfunctional Well Differentiated Neuroendocrine Neoplasm
- Interventions
- Carbon C 11 Alpha-methyltryptophan, Laboratory Biomarker Analysis, Positron Emission Tomography, Telotristat Etiprate
- First posted
- 2018-03-05
- Last updated
- 2025-04-10
- Results first posted
- 2025-04-10
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Proportion of Patients Who Achieved SUVmax Reduction of 20% or More Between Baseline and Follow up Scan | Baseline up to follow up, assessed up to 3 months | The proportion of patients who achieved maximum standardized uptake value (SUVmax) reduction of 20% or more between baseline and follow up scan. It will be reported with a one-sided, 90% confidence limit. |
| Secondary | Change in Mean Standardized Uptake Value (SUVmean) | Baseline up to 3 months | Will be reported as percent change with two-sided 95% confidence intervals. Paired t test will be used for pre-and post-treatment SUVs if normality assumption holds. |
| Secondary | Neuroendocrine Tumors Visibility | At baseline | Proportion of patients with visible neuroendocrine tumors at baseline out of total number of patients. The outcome will be reported as proportion and 95% CI |
| Secondary | Difference in SUVmax of AMT Uptake Between the Tumor Mass and Background at Baseline | Baseline | Difference will be reported as percent of (SUVmax.tumor - SUVmax.background)/SUVmax.background in the baseline scan with 95% Confidence Interval |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Proportion of Patients Who Achieved SUVmax Reduction of 20% or More Between Baseline and Follow up Scan | Baseline up to follow up, assessed up to 3 months | Proportion of participants | NUMBER | |
| SECONDARY | Change in Mean Standardized Uptake Value (SUVmean) | Baseline up to 3 months | Percentage change | MEAN | |
| SECONDARY | Neuroendocrine Tumors Visibility | At baseline | Proportion of participants | NUMBER | |
| SECONDARY | Difference in SUVmax of AMT Uptake Between the Tumor Mass and Background at Baseline | Baseline | Percentage | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Proportion of Patients Who Achieved SUVmax Reduction of 20% or More Between Baseline and Follow up Scan | Treatment (AMT-PET, Telotristat Etiprate) | 0 | 90% Confidence Interval 0 to 1 | Proportion of participants | |
| Change in Mean Standardized Uptake Value (SUVmean) | Treatment (AMT-PET, Telotristat Etiprate) | 46.01 | 95% Confidence Interval -56.06 to 148.08 | Percentage change | |
| Neuroendocrine Tumors Visibility | Treatment (AMT-PET, Telotristat Etiprate) | 1 | 95% Confidence Interval 0.51 to 1 | Proportion of participants | |
| Difference in SUVmax of AMT Uptake Between the Tumor Mass and Background at Baseline | Treatment (AMT-PET, Telotristat Etiprate) | 451.90 | 95% Confidence Interval 271.21 to 632.60 | Percentage |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (AMT-PET, Telotristat Etiprate) | 4 | |
| Overall Study | COMPLETED | Treatment (AMT-PET, Telotristat Etiprate) | 4 | |
| Overall Study | NOT COMPLETED | Treatment (AMT-PET, Telotristat Etiprate) | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (AMT-PET, Telotristat Etiprate) | 0 | 4 |
| Total, other adverse events | Treatment (AMT-PET, Telotristat Etiprate) | 0 | 4 |
| Total, serious adverse events | Treatment (AMT-PET, Telotristat Etiprate) | 0 | 4 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA022453 | CANCER CENTER SUPPORT GRANT | PASCHE, BORIS | WAYNE STATE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03453489
GET https://conductscience.org/api/trials/v1/NCT03453489/registered