Clinical trial · Interventional
A Feasibility Study of Gallium-68 Citrate PET to Detect Aberrant MYC Proto-Oncogene, BHLH Transcription Factor (MYC) Protein Expression in Diffuse Large B-Cell Lymphoma
A Feasibility Study of Gallium-68 Citrate PET to Detect Aberrant MYC Protein Expression in Diffuse Large B-Cell Lymphoma
NCT02776891CI-TRIAL-00041084withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Unexpected dose production issues prevented study start up
Summary
Brief summary (as posted)
This is a single center imaging study investigating the use of PET with 68Ga-citrate in patients with DLBCL or BCLU.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Burkitt Lymphoma | Burkitt Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Lymphoma, Large B-Cell, Diffuse | Lymphoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gallium citrate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gallium citrate
- description
- 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.
- interventionNames
- Drug: Gallium citrate
Primary outcomes (1)
- measure
- Uptake of radiotracer in tumor tissue
- timeFrame
- 16 months
- description
- 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.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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 2. Presence of palpable or radiographically measurable disease of at least 1.5 cm in longest dimension. 3. Available prior CT or PET/CT scan done in the last 8 weeks for comparison 4. Prior chemotherapy or radiation to the measurable lesion must be completed at least 14 days prior. 5. Adequate renal function with estimated creatinine clearance ≥50 mL/min (by the Cockcroft Gault equation) 6. No contraindications to MRI (e.g. pacemaker, aneurysm clips, severe claustrophobia) 7. 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. 8. Age ≥18 years old Exclusion Criteria: 1. 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 2. Body weight over 300 pounds 3. Female patients who are pregnant or breast-feeding 4. Prior MRI with gadolinium performed \<24 hours before the study scan 5. No red blood cell transfusion or iron administration by any route in the last 7 days 6. Prior hypersensitivity or intolerance to gadolinium or gallium citrate.
References
Publications (0)
Data not yet available
No reference posted for this study.