Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06395402
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-04-25
Brief Title:
177Lu-DOTATATE Modified Delivery Based on Individualized Dosimetry
Sponsor:
University of Iowa
Organization:
University of Iowa
Study Overview
Official Title:
177Lu-DOTATATE Modified Delivery Based on Individualized Dosimetry
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LUMOD-ID
Brief Summary:
The goal of this study is to learn if individualized dosimetry-based prescribing of Lutetium-177 DOTATATE Lutathera Novartis Pharmaceuticals improves treatment outcomes for adults with unresectable neuroendocrine tumors To investigate this study participants will
Undergo Somatostatin Receptor SSTR positron emission tomography PET imaging such as a DOTATOC PETCT scan
Be randomized to receive standard treatment as per FDA guidelines or investigational treatment customized dosing of Lutathera based upon dosimetry
Undergo blood tests for 4 to 8 weeks after each Lutathera treatment
Complete patient reported outcome questionnaires
Visit the clinic for follow-up about every 8 weeks
Undergo Somatostatin Receptor SSTR positron emission tomography PET imaging such as a DOTATOC PETCT scan
Be randomized to receive standard treatment as per FDA guidelines or investigational treatment customized dosing of Lutathera based upon dosimetry
Undergo blood tests for 4 to 8 weeks after each Lutathera treatment
Complete patient reported outcome questionnaires
Visit the clinic for follow-up about every 8 weeks
Detailed Description:
This is a randomized controlled clinical trial evaluating the impact of forward planning dosimetry for Lutetium-177 DOTATATE Lutathera Novartis Pharmaceuticals a radiopharmaceutical approved to treat neuroendocrine tumors by the US FDA
If a patient consents to participate and is deemed eligible to move forward there is a 2 out of 3 chance to receive the investigational treatment the Lutathera treatment customized to tumor uptake and kidney uptake The standard treatment is 200 millicuries mCi of Lutathera per cycle with potential adjustments for safety per the FDA-approved package insert
Regardless of the assigned group investigational treatment or standard treatment the first treatment is 200 mCi This is given with amino acids which is required for this treatment
Participants in the standard treatment continue to receive 200 mCi per treatment with or without adjustment based on package insert instructions for up to 4 treatments total
Participants in the investigational treatment will receive a customized dose of Lutathera up to 400 mCi per treatment for treatments 2 - 4 in the hopes that escalation will be safe and effective in many patients based on individualized dosimetry
Participants randomized to the investigational treatment will receive specialized imaging SPECTCT following administration of Lutathera This will identify where the Lutathera went and how long it remains there in the tumors kidneys or bone marrow After the first dose of Lutathera this imaging is done on the first day of treatment and then once a day for the next 3 to 4 days Each scan lasts about an hour Following treatments 2 and 3 this imaging is only done on the first day and then once at about 3 to 4 days after the treatment There are also blood samples collected to measure the radioactivity in the blood
All participants must be actively followed to assess for side effects of therapy as well as treatment outcomes This means participants must return to the treatment site at 2 3 6 and 12 months after the last cycle of therapy All participants must have a CT scan completed at 6 months after treatment as well
Radiation side effects can take years to develop For this reason it is very important that participants remain in touch with the study investigator and team Participants have life-long follow-up for this study
If a patient consents to participate and is deemed eligible to move forward there is a 2 out of 3 chance to receive the investigational treatment the Lutathera treatment customized to tumor uptake and kidney uptake The standard treatment is 200 millicuries mCi of Lutathera per cycle with potential adjustments for safety per the FDA-approved package insert
Regardless of the assigned group investigational treatment or standard treatment the first treatment is 200 mCi This is given with amino acids which is required for this treatment
Participants in the standard treatment continue to receive 200 mCi per treatment with or without adjustment based on package insert instructions for up to 4 treatments total
Participants in the investigational treatment will receive a customized dose of Lutathera up to 400 mCi per treatment for treatments 2 - 4 in the hopes that escalation will be safe and effective in many patients based on individualized dosimetry
Participants randomized to the investigational treatment will receive specialized imaging SPECTCT following administration of Lutathera This will identify where the Lutathera went and how long it remains there in the tumors kidneys or bone marrow After the first dose of Lutathera this imaging is done on the first day of treatment and then once a day for the next 3 to 4 days Each scan lasts about an hour Following treatments 2 and 3 this imaging is only done on the first day and then once at about 3 to 4 days after the treatment There are also blood samples collected to measure the radioactivity in the blood
All participants must be actively followed to assess for side effects of therapy as well as treatment outcomes This means participants must return to the treatment site at 2 3 6 and 12 months after the last cycle of therapy All participants must have a CT scan completed at 6 months after treatment as well
Radiation side effects can take years to develop For this reason it is very important that participants remain in touch with the study investigator and team Participants have life-long follow-up for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None