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Radioisotope Therapy

SPECT CT Dosimetry for Adenoid Cystic Carcinoma

Phase 2

Waitlist Available

Led By Ana Kiess, MD, PhD

Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months post treatment

Awards & highlights

Study Summary

This trial is for people with a specific type of cancer that has come back or spread and cannot be removed with surgery. The trial will involve 10 participants at Johns Hopkins who will undergo imaging tests to

Who is the study for?

This trial is for people with recurrent or metastatic adenoid cystic carcinoma that's not suitable for surgery. Participants will be part of a study at Johns Hopkins, undergoing special imaging and possibly treatment with the drug 177Lu-PNT2002 if they move to Cohort 2 after initial assessments.Check my eligibility

What is being tested?

The trial is testing the use of a radioactive drug called 177Lu-PNT2002 in patients with specific cancer. Initially, participants undergo diagnostic imaging; if results are favorable, they may receive the actual treatment in Cohort 2.See study design

What are the potential side effects?

Potential side effects aren't specified here but generally, radioactive drugs like 177Lu-PSMA can cause nausea, dry mouth, fatigue, and temporary changes in blood counts.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Absorbed dose in tumor and normal organs

Objective response rate (ORR) by RECIST 1.1 measured in patients treated with 177Lu-PSMA for recurrent and metastatic ACC.

Secondary outcome measures

Duration of Response

European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module (EORTC QLQ-HN43)

Overall Survival

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: SPECT CT DosimetryExperimental Treatment1 Intervention

Absorbed dose in tumor and normal organs will by measured using SPECT/CT dosimetry in Cohort 1.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor

558 Previous Clinical Trials

32,910 Total Patients Enrolled

Adenoid Cystic Carcinoma Research FoundationOTHER

6 Previous Clinical Trials

209 Total Patients Enrolled

Progenics Pharmaceuticals, Inc.Industry Sponsor

33 Previous Clinical Trials

4,940 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the specific objectives of this research study?

"The primary aim of this clinical study, to be assessed following a single administration within one day, is the Objective Response Rate (ORR) according to RECIST 1.1 criteria in patients undergoing treatment with 177Lu-PSMA for recurrent and metastatic ACC. Secondary aims encompass evaluating Progression-Free Survival—inclusive only if Cohort 2 enrolment is successful: progression-free survival will be depicted using Kaplan-Meier analysis; median values alongside 95% Confidence Intervals will be calculated and disclosed—European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module (EORTC QLQ"

Answered by AI

Does the FDA endorse the use of SPECT CT Dosimetry for medical purposes?

"Our team at Power has appraised the safety level of SPECT CT Dosimetry to be 2 on a scale ranging from 1 to 3. This rating reflects that, as a Phase 2 trial, there exists some evidence endorsing its safety profile without any data yet substantiating efficacy."

Answered by AI

Are there any available vacancies for potential participants in this research study?

"As per the details on clinicaltrials.gov, recruitment for this study is currently closed. The trial was initially listed on April 1st, 2024, with the most recent update made on March 14th, 2024. However, individuals interested in participating in a research study still have access to 2567 other ongoing trials that are actively enrolling participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

177Lu-PSMA (177Lu-PNT2002) in PSMA-Positive Adenoid Cystic Carcinoma

2024. "177Lu-PSMA (177Lu-PNT2002) in PSMA-Positive Adenoid Cystic Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06322576.

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