Trial · NCT03432741
Direct Tumor Microinjection and FDG-PET in Testing Drug Sensitivity in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Stage IV Breast Cancer
NCT03432741, Phase 1, Terminated, Mayo Clinic
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Direct Tumor Microinjection and FDG-PET in Testing Drug Sensitivity in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Stage IV Breast Cancer. Trials, record NCT03432741. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03432741
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Direct Tumor Microinjection and FDG-PET in Testing Drug Sensitivity in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Stage IV Breast Cancer
- NCT number
- NCT03432741
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 17 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
Breast Adenocarcinoma, Metastatic Breast Carcinoma, Recurrent Breast Carcinoma, Recurrent Hodgkin Lymphoma, Recurrent Mycosis Fungoides, Recurrent Non-Hodgkin Lymphoma, Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory Breast Carcinoma, Refractory Hodgkin Lymphoma, Refractory Mycosis Fungoides, Refractory Nodal Marginal Zone Lymphoma, Refractory Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Stage IV Breast Cancer AJCC v6 and v7
- Interventions
Belinostat, Carfilzomib, Copanlisib Hydrochloride, Daratumumab, Fludeoxyglucose F-18, Gemcitabine Hydrochloride, Laboratory Biomarker Analysis, Nivolumab, Obinutuzumab, Pembrolizumab, Positron Emission Tomography, Rituximab, Romidepsin, Saline, Trastuzumab
- First posted
- 2018-02-14
- Last updated
- 2025-05-26
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of drug sensitivity as measured by injection site skin reaction | Up to 3 months | Skin reactions will be assessed using the Cancer Therapy Evaluation Program (CTEP) active version of the Common Terminology Criteria for Adverse Events (CTCAE) and will consist of any grade 3 or higher treatment-related pain, skin or subcutaneous tissue disorders. Incidence rates of skin reactions will be estimated by the number of patients with reactions divided by the total number of evaluable patients per disease type. Exact binomial 95% confidence intervals for the true incidence rate will be calculated. |
| Secondary | Feasibility | Up to 3 months | For Cohort I (Arms A \& B) and Cohort II (Arm D): The study will be determined to be feasible if at least 70% of the enrolled patients complete the injection and response evaluation. The feasibility rate will be estimated by the number of patients completed divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true feasibility rate will be calculated. For Cohort II (Arm C): The feasibility rate will be evaluated for the device regarding whether the device will be able to target the affected lymph nodes in at least 50% of the time. The feasibility rate will be estimated by the number of patients completed divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true feasibility rate will be calculated. |
| Secondary | Nodal disease response rate | Up to 5 days post injection | Defined as a decrease in standardized uptake value (SUV) uptake by 25% at site of injection. Will be estimated by the number of injection sites with responses divided by the total number of injected sites. Exact binomial 95% confidence intervals for the true overall response rate will be calculated. |
| Secondary | Cutaneous response rate based upon the modified Severity Weighted Assessment Tool score | Up to 7 days post injection | Will be estimated by the number of injection sites with responses divided by the total number of injected sites. Exact binomial 95% confidence intervals for the true overall response rate will be calculated. |
| Secondary | Incidence of adverse events | Up to 3 months | Will be evaluated using the CTEP active version of the CTCAE. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. |
| Other | Apoptosis in response to intratumoral injection | Up to 3 months | Will assess using morphology (evidence of necrosis), measurement by immunohistochemistry of Ki67 (a marker of cell proliferation) and cleaved Caspace-3. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
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 totals0
The totals the trial posted for each group.
None in this release.
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 |
|---|---|---|---|---|---|
| P30CA015083 | Mayo Clinic Comprehensive Cancer Center Support Grant | WILLMAN, CHERYL LYNN | MAYO CLINIC ROCHESTER | 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/NCT03432741
GET https://conductscience.org/api/trials/v1/NCT03432741/registered