NCT02776891

Brief Summary

This is a single center imaging study investigating the use of PET with 68Ga-citrate in patients with DLBCL or BCLU.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2016

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 18, 2016

Completed
26 days until next milestone

Study Start

First participant enrolled

June 13, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2018

Completed
Last Updated

October 10, 2019

Status Verified

October 1, 2019

Enrollment Period

1.8 years

First QC Date

May 17, 2016

Last Update Submit

October 8, 2019

Conditions

Lymphoma, Large B-Cell, DiffuseBurkitt Lymphoma

Keywords

lymphomagallium citratePET

Outcome Measures

Primary Outcomes (1)

  • Uptake of radiotracer in tumor tissue

    To show evidence of specific uptake of the radiotracer in the tumor tissue compared to background. For exploratory radiotracer studies, this is typically defined as 1.5-2 fold increase in SUVmax in the tumor compared to mediastinal blood pool activity.

    16 months

Secondary Outcomes (1)

  • Comparing Gallium citrate uptake

    16 months

Study Arms (1)

Gallium citrate

EXPERIMENTAL

The patients will be organized into two cohorts. Cohort 1 will receive 10 mCi and will be imaged 4 and 6 hours post injection. Cohort 2 will receive 15 millicurie (mCi) and will be imaged 4 and 6 hours post injection. Cohort 2 will be imaged if the optimal protocol identified image quality from cohort 1 does not allow for the resolution of cancer lesions.

Drug: Gallium citrate

Interventions

Gallium citrateDRUG

Ga-68 citrate will be administered on an outpatient basis at the Center for Molecular and Functional Imaging at China Basin. It will be administered a single time point intravenously prior to PET imaging. The one-time nominal injected dose will be up to 15 mCi containing 10 - 25 μg Ga-68. A simultaneous MRI (PET/MRI) of the head will be used for attenuation correction and anatomic localization of gallium-68 citrate uptake and standardized uptake value (SUV) calculation.

Also known as: Ga-68 citrate
Gallium citrate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed DLBCL or BCLU.
  • Double hit lymphoma, defined by positive cytogenetic/ fluorescence in situ hybridization (FISH) analysis for translocations involving myc and bcl2 or a double hit score of 2 by immunohistochemistry as described by Johnson et al.
  • DLBCL without myc translocation or overexpression by the above methods
  • Presence of palpable or radiographically measurable disease of at least 1.5 cm in longest dimension.
  • Available prior CT or PET/CT scan done in the last 8 weeks for comparison
  • Prior chemotherapy or radiation to the measurable lesion must be completed at least 14 days prior.
  • Adequate renal function with estimated creatinine clearance ≥50 mL/min (by the Cockcroft Gault equation)
  • No contraindications to MRI (e.g. pacemaker, aneurysm clips, severe claustrophobia)
  • Ability to sign a study-specific internal review board (IRB) approved consent prior to study entry. Patients must be able and willing to consent and undergo study procedures.
  • Age ≥18 years old

You may not qualify if:

  • Any serious and/or unstable pre-existing medical, psychiatric, or other medical condition that could interfere with subject's safety, provision of informed consent, or compliance with study procedures
  • Body weight over 300 pounds
  • Female patients who are pregnant or breast-feeding
  • Prior MRI with gadolinium performed \<24 hours before the study scan
  • No red blood cell transfusion or iron administration by any route in the last 7 days
  • Prior hypersensitivity or intolerance to gadolinium or gallium citrate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lymphoma, Large B-Cell, DiffuseBurkitt LymphomaLymphoma

Interventions

gallium citrate

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus Infections

Study Officials

  • Michael Evans, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2016

First Posted

May 18, 2016

Study Start

June 13, 2016

Primary Completion

April 9, 2018

Study Completion

April 9, 2018

Last Updated

October 10, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share