Follow-up Yttrium-90 Internal Pair Production PET/CT vs Brehmsstrahlung Imaging in Patients With Primary/Metastatic Liver Tumors

• ClinicalTrials.gov Identifier: NCT02202317
• Recruitment Status: Completed
• First Posted: July 29, 2014
• Results First Posted: December 29, 2017
• Last Update Posted: December 29, 2017
• Sponsor: University of Miami
• Information provided by (Responsible Party): Jason Salsamendi, University of Miami

Tracking Information

• First Submitted Date: July 24, 2014
• First Posted Date: July 29, 2014
• Results First Submitted Date: November 1, 2017
• Results First Posted Date: December 29, 2017
• Last Update Posted Date: December 29, 2017
• Study Start Date: April 2013
• Actual Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 27, 2017)

Number of Subjects Whose Y-90 Based PET/CT (Positron Emission Tomography/Computed Tomography)Scans Detected Extrahepatic Non-target Embolization. [ Time Frame: 12 months ]

Number of participants with detected extrahepatic non-target embolization. A qualitative comparison between the two modalities (Y-90 PET/CT and Brehmsstrahlung SPECT) as to the conspicuity of the abnormality would have been conducted had any participant had that result.

Original Primary Outcome Measures (submitted: July 24, 2014)

Percentage of subjects whose Y-90 based PET/CT Scans detected non-target embolization where applicable. [ Time Frame: 12 months ]

Detection of non-target embolization, where applicable, and qualitative comparison between the two modalities (Y-90 PET/CT and Brehmsstralung SPECT) as to the conspicuity of the abnormality.

Current Secondary Outcome Measures (submitted: December 27, 2017)

• Comparison Between Treatment Distribution Depicted by Tc99mMAA (Technetium-99m Macroaggregated Albumin) Brehmsstrahlung Scans vs. the Internal Pair Production PET/CT Scans. [ Time Frame: 12 months ]
  Number of participants demonstrating a similar treatment distribution depicted by Tc99mMAA(Technetium-99m macroaggregated albumin) Brehmsstrahlung scans vs. achieved Y-90 distribution on the Internal Pair Production PET/CT scans.
• Comparison of Y-90 PET/CT to Y90 SPECT [ Time Frame: 12 Months ]
  Number of participants with a similar Y90 distribution depicted on Post Y90 delivery PET/CT and SPECT modalities, specifically comparing Y90 distribution within the treated tumors.

Original Secondary Outcome Measures (submitted: July 24, 2014)

• Degree of correlation between treatment distribution depicted by Brehmsstrahlung scans vs. the Internal Pair Production PET/CT scans [ Time Frame: 12 months ]
  Degree of correlation between treatment distribution depicted by Brehmsstrahlung scans vs. the Internal Pair Production PET/CT scans, to include an assessment/comparison of the precision of anatomic localization achieved by the two modalities.
• Degree of correlation with expected vs. achieved tumor coverage by the treatment [ Time Frame: 12 Months ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Follow-up Yttrium-90 Internal Pair Production PET/CT vs Brehmsstrahlung Imaging in Patients With Primary/Metastatic Liver Tumors
• Official Title: Follow-up Yttrium-90 Internal Pair Production PET/CT Imaging in Patients With Primary or Metastatic Liver Tumors as Compared With Brehmsstrahlung Imaging: A Prospective Case Series

Brief Summary

This is a prospective non-blinded case series involving the acquisition of a pair production PET/CT as soon as possible after an already performed Y-90 Sirspheres treatment of hepatic malignancy. It will be performed in addition to the standard Brehmsstrahlung SPECT scan. The sequence of the two scans in each case (PET/CT vs SPECT) will be determined by availability of the scanners at the time. However, it is intended that both be acquired on the day of the Y-90 treatment.

The length of subject participation will be one year.

The measures used will be mostly qualitative in nature, and will include:

• Correlation with expected vs. achieved tumor coverage by the treatment
• Correlation between treatment distribution depicted by Brehmsstrahlung scans vs. the Internal Pair Production PET/CT scans, to.
• Detection of non-target embolization, where applicable, and qualitative comparison between the two modalities as to the conspicuity of the abnormality

Qualitative methods will be used by the analysis of the obtained PET/CT images and comparing them to the Brehmsstrahlung SPECT images as previously described.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Screening

Condition

• Liver Cancer
• Hepatic Tumors

Intervention

Device: PET/CT Scan

Subjects will receive a PET/CT Scan in addition to SPECT imaging, from the level of the lower chest to the lower pelvis, typical of an abdominal CT, usually within 1-3 hours after Yttrium-90 treatment.

Study Arms

Experimental: Y90 Based PET/CT Scan

Intervention: Device: PET/CT Scan

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 4, 2016): 9
• Original Estimated Enrollment (submitted: July 24, 2014): 10
• Actual Study Completion Date: October 2016
• Actual Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Recipient of Selective Internal Radiation Treatment within 5 days.
• Anticipated ability to remain still for up to 40 minutes

Exclusion Criteria:

• Anticipated Inability to lie still for up to 40 minutes
• Severe claustrophobia
• Significant cardiovascular instability, or instability of other medical/surgical conditions, such that it would be deemed unsafe or technically not feasible to obtain a PET/CT, as determined by the any member of the investigative team
• Failed deployment of the planned Y-90 treatment for any reason
• Duration of time longer than 5 days since administration of the Y-90 treatment
• Age <18
• Known pregnancy

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02202317
• Other Study ID Numbers: 20120092
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Jason Salsamendi, University of Miami
• Study Sponsor: University of Miami
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jason Salsamendi, MD; University of Miami

• PRS Account: University of Miami
• Verification Date: December 2017