Radioisotope Therapy
177Lu-DOTA-EB-TATE for Neuroendocrine Tumors
Phase 1
Recruiting
Led By Lisa Bodei, MD, PhD
Research Sponsored by Molecular Targeting Technologies, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Karnofsky performance status scale ≥ 70%
Be older than 18 years old
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up16-17 months
Awards & highlights
No Placebo-Only Group
Study Summary
This trial is to test a new treatment for a rare cancer. It will study how well the treatment works and what side effects it may have.
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You are able to perform daily activities with at least 70% of your usual energy and ability.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16-17 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16-17 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To determine if the maximum tolerated dose is among the explored doses of 50, 100 and 150 mCi.
To evaluate the safety of 177Lu-DOTA-EB-TATE assessed from the number of patients with treatment-related adverse events.
To identify the dose-limiting toxicities (DLTs) of escalating doses of 177Lu-DOTA-EB-TATE up to 150 mCi.
Secondary outcome measures
To evaluate dosimetry levels in patients following 2 cycles of 177Lu-DOTA-EB-TATE.
Therapeutic procedure
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Peptide Receptor Radionucleotide Therapy (PRRT)Experimental Treatment2 Interventions
The treatment regimen will consist of a single-dose intravenous administration of 177Lu-DOTA-EB-TATE per 6-week cycle, for a total of 2 cycles. The dose per cycle will be fixed for each patient and will be escalated in 3 different dose levels, from 50 mCi to 150 mCi (1.85 -5.55 GBq). Each dose of 177Lu-DOTA-EB-TATE will be administered in association with intravenous renal protective amino acid solutions.
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Who is running the clinical trial?
Molecular Targeting Technologies, Inc.Lead Sponsor
2 Previous Clinical Trials
72 Total Patients Enrolled
ClinSmartIndustry Sponsor
1 Previous Clinical Trials
18 Total Patients Enrolled
Lisa Bodei, MD, PhDPrincipal Investigator
Memorial Sloan Kettering Cancer Center1 Previous Clinical Trials
10 Total Patients Enrolled
1 Trials studying Neuroendocrine Tumors
10 Patients Enrolled for Neuroendocrine Tumors
Media Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what degree is 177Lu-DOTA-EB-TATE hazardous to human health?
"Owing to the data collected during Phase 1, our team at Power has assigned a score of 1 for 177Lu-DOTA-EB-TATE's safety rating. This indicates that there is limited evidence attesting to its efficacy and security."
Answered by AI
How many participants are enrolled in this experimental research?
"Affirmative. According to the information available on clinicaltrials.gov, this medical investigation is actively recruiting patients and has been since its initial posting date of June 18th 2022. 9 applicants are required from 1 location for the successful completion of this trial."
Answered by AI
Are enrollees still being accepted into this research trial?
"Affirmative. According to the information published on clinicaltrials.gov, this trial initially posted on June 18th 2022 is currently recruiting participants. A total of 9 participants need to be enrolled from 1 medical site."
Answered by AI
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