Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06298916
Status:
RECRUITING
Last Update Posted:
2024-03-07
First Post:
2024-02-22
Brief Title:
64Cu-LNTH-1363S in Patients with Sarcoma or Gastrointestinal Tract Cancer
Sponsor:
Lantheus Medical Imaging
Organization:
Lantheus Medical Imaging
Study Overview
Official Title:
A Phase 12a Study Utilizing 64Cu-LNTH-1363S 64Cu Radiolabeled FAPi PETCT Imaging Agent in Patients with Sarcoma or Gastrointestinal Tract Cancer PHANTOM Trial
Status:
RECRUITING
Status Verified Date:
2024-10
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:
PHANTOM
Brief Summary:
This is a multicenter open-label prospective Phase 12a study to assess safety and tolerability establish dosimetry and to identify an optimal imaging dose radioactivity and mass dose and imaging time window of 64Cu-LNTH-1363S 64Cu Radiolabeled FAPi PETCT Imaging Agent and to compare its imaging biodistribution with FAP expression by immunohistochemistry IHC in patients with sarcomas or GIT cancers The study will be conducted in 2 parts Part 1 and Part 2
Detailed Description:
Part 1 will determine the biodistribution dosimetry optimal dose radioactivity and mass dose and imaging time window of 64Cu-LNTH-1363S in 12 evaluable patients with supposed FAP-expressing solid tumors metastatic sarcomas Two 64Cu-LNTH-1363S mass doses of 50 μg and 90 μg will be studied Six patients will receive 8 1 millicurie mCi 50 μg mass dose followed by another 6 patients will receive 8 1 mCi 90 μg mass dose Two additional radioactivity 6 and 4 mCi doses will be simulated by reprocessing raw data from each patients PET scans
This study does not involve randomization for dose groups It will commence with the lower dose group 50 μg mass dose After enrolling 6 evaluable patients in this dose group recruitment for the next dose group 90 μg mass dose will begin and conclude upon enrolling 6 evaluable patients Subsequently the images will undergo analysis by blinded central readers
Part 1 of the study will last approximately 3 weeks for each patient and includes a Screening Period up to 14 days a 1-day Intervention Period and a Safety Follow-up Period 7 days post dose
Part 2 will evaluate 64Cu-LNTH-1363S imaging correlation with FAP expression measured by IHC SUVmax and SUVmean vs IHC score in 20 evaluable patients with non-metastatic operable supposed FAP-expressing solid tumors sarcomas esophageal gastric pancreatic colorectal planned for surgery within 60 days from study imaging If the optimal radioactivity determined from Part 1 is less than 8 1 mCi the first 6 patients in Part 2 will be used to validate this optimal radioactivity This mean the image quality scores of the first 6 patients will need to be calculated If the sum of the average image quality scores of the 6 patients is higher or equal to 105 then the lower optimal radioactivity determined in Part 1 will be used for the remaining 14 patients otherwise the remaining 14 patients in Part 2 will be injected with 8 1 mCi of 64Cu-LNTH-1363S Part 2 of the study will last approximately 10 to 11 weeks for each patient and includes a Screening Period up to 14 days a 1-day Intervention Period a 1-day Safety Follow-up Period Day 2 and a Scheduled Surgery IHC Sample Collection Period from Day 2 to Day 60
Both Part 1 and Part 2 of the study will also monitor cardiac safety by detecting changes in HR T wave ST segment and other ECG parameters and look for signals suggesting a concentration-response relationship of 64Cu-LNTH-1363S for QT and corrected QT interval QTc prolongation
This study does not involve randomization for dose groups It will commence with the lower dose group 50 μg mass dose After enrolling 6 evaluable patients in this dose group recruitment for the next dose group 90 μg mass dose will begin and conclude upon enrolling 6 evaluable patients Subsequently the images will undergo analysis by blinded central readers
Part 1 of the study will last approximately 3 weeks for each patient and includes a Screening Period up to 14 days a 1-day Intervention Period and a Safety Follow-up Period 7 days post dose
Part 2 will evaluate 64Cu-LNTH-1363S imaging correlation with FAP expression measured by IHC SUVmax and SUVmean vs IHC score in 20 evaluable patients with non-metastatic operable supposed FAP-expressing solid tumors sarcomas esophageal gastric pancreatic colorectal planned for surgery within 60 days from study imaging If the optimal radioactivity determined from Part 1 is less than 8 1 mCi the first 6 patients in Part 2 will be used to validate this optimal radioactivity This mean the image quality scores of the first 6 patients will need to be calculated If the sum of the average image quality scores of the 6 patients is higher or equal to 105 then the lower optimal radioactivity determined in Part 1 will be used for the remaining 14 patients otherwise the remaining 14 patients in Part 2 will be injected with 8 1 mCi of 64Cu-LNTH-1363S Part 2 of the study will last approximately 10 to 11 weeks for each patient and includes a Screening Period up to 14 days a 1-day Intervention Period a 1-day Safety Follow-up Period Day 2 and a Scheduled Surgery IHC Sample Collection Period from Day 2 to Day 60
Both Part 1 and Part 2 of the study will also monitor cardiac safety by detecting changes in HR T wave ST segment and other ECG parameters and look for signals suggesting a concentration-response relationship of 64Cu-LNTH-1363S for QT and corrected QT interval QTc prolongation
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?:
None
Is an FDA AA801 Violation?:
None