Trial · NCT06322576
177Lu-PSMA (177Lu-PNT2002) in PSMA-Positive Adenoid Cystic Carcinoma
NCT06322576, Phase 2, Terminated, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 177Lu-PSMA (177Lu-PNT2002) in PSMA-Positive Adenoid Cystic Carcinoma. Trials, record NCT06322576. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06322576
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 177Lu-PSMA (177Lu-PNT2002) in PSMA-Positive Adenoid Cystic Carcinoma
- NCT number
- NCT06322576
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 1 participants, actual
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Conditions
- Adenoid Cystic Carcinoma
- Interventions
- 177Lu-PNT2002
- First posted
- 2024-03-21
- Last updated
- 2026-01-22
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Absorbed dose in tumor and normal organs | One dose during one day | Objective is to measure absorbed dose in tumor and normal organs using SPECT/CT dosimetry (Cohort 1) |
| Primary | Objective response rate (ORR) by RECIST 1.1 measured in patients treated with 177Lu-PSMA for recurrent and metastatic ACC. | Pre-treatment, 6 months post treatment | Only relevant for Cohort 2 patients: Measure response rate (ORR) by RECIST 1.1 in participants treated with 177Lu-PSMA for recurrent and metastatic ACC. |
| Secondary | Stability of Disease: Proportion of patients with Stable Disease | 6 months post treatment | Cohort 2 participants only. Stability of disease at 6 months is defined as the proportion of patients with SD as assessed per RECIST 1.1 at 6 months after the last cycle of treatment. This 6-month post treatment time point will vary based on the total number of cycles the patient receives. |
| Secondary | Progression Free Survival | 24 months after Day 1, Cycle 1 of treatment (each cycle is 8 weeks) | Only relevant if able to enroll Cohort 2 patients: The distribution of progression free survival will be plotted using the Kaplan Meier method and median values will be estimated and reported with 95% CIs |
| Secondary | Overall Survival | 24 months after Day 1, Cycle 1 of treatment (each cycle is 8 weeks) | Only relevant if able to enroll Cohort 2 patients: The distribution of overall survival will be plotted using the Kaplan Meier method and median values will be estimated and reported with 95% CIs |
| Secondary | Duration of Response | 24 months after Day 1 of treatment | Cohort 2 participants only. Objective response will be defined as evidence of CR, PR, or stable disease. The duration of response will be measured from the start of treatment until the criteria for progression are met. Duration of CR or PR: The duration of response (DoR) of CR or PR will be recorded from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that current or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Duration of Stable Disease: Stable disease is measured from the start of the treatment until the criteria for progression are met, taking as reference the smallest measurements recorded since the treatment started. |
| Secondary | Xerostomia questionnaire (XQ) score | 24 months after Day 1 of treatment | Only relevant if able to enroll Cohort 2 patients: Xerostomia questionnaire (XQ) will be completed by patients at baseline, prior to each dose of 177Lu-PSMA, at end of treatment, and at follow up visits. XQ measures severity of radiation-induced xerostomia and patient reported quality of life. 8 question total:4 on dryness while eating/chewing, 4 on dryness when not eating/chewing. 0-10 (higher scores=severe dryness/discomfort). Composite Scores range from 0 (no xerostomia) -100 (highest level of xerostomia). |
| Secondary | European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module (EORTC QLQ-HN43) | 24 months after Day 1 of treatment | Only relevant if able to enroll Cohort 2 patients: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module (EORTC QLQ-HN43) will be completed by patients at baseline, prior to each dose of 177Lu-PSMA, at end of treatment, and at follow up visits. Answers given according to a 4-point Likert scale, and then transformed so that 0% indicated least symptoms, and 100% most symptoms. |
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.
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
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/NCT06322576
GET https://conductscience.org/api/trials/v1/NCT06322576/registered