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Using a PET Imaging Agent, 18F-Clofarabine (CFA), to Measure Deoxycytidine Kinase Activity in Metastatic Cancer

Primary Purpose

Metastatic Cancer, Carcinoma, Adenocarcinoma

Status

Active

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

18F-Clofarabine

About this trial

This is an interventional diagnostic trial for Metastatic Cancer focused on measuring 18F-Clofarabine, Diagnostic Imaging, Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histologically or cytologically proven carcinoma or adenocarcinoma. Histologies other than carcinoma/adenocarcinoma will not be eligible.
Subjects must have metastatic disease, confirmed by imaging, typically a CT scan of the chest/abdomen/pelvis.
Subjects must have measurable disease per RECIST 1.1
Over 18 years of age
ECOG performance status 0-1
Adequate organ function as defined by the following criteria:

Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) <= 2.5 x laboratory upper limit of normal (ULN)

Total serum bilirubin <= 2.0 x ULN

Absolute neutrophil count (ANC) >= 1500/uL

Platelets >= 75,000/uL

Hemoglobin >= 8.0 g/dL

Serum calcium <= 12.0 mg/dL

Serum creatinine <= 2.9 mg/dL

Subjects must have the ability to understand and the willingness to sign a written informed consent document
Patient is able to remain still for the duration of the imaging procedure (up to one hour).

Exclusion Criteria:

Within 6 months prior to enrollment on this study: myocardial infarction, severe/unstable angina, severe peripheral vascular disease (claudication) or procedure on peripheral vasculature, coronary/peripheral artery bypass graft, New York Heart Association grade II or greater congestive heart failure, cerebrovascular accident or transient ischemic attack, clinically significant bleeding or pulmonary embolism.
Pregnancy or breastfeeding (pregnant or breastfeeding women are excluded from this study because study drugs have the potential for teratogenic or abortifacient effects.
Other severe acute or chronic medical or psychiatric conditions or laboratory abnormalities that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.

Sites / Locations

Cleveland Clinic, Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18F-Clofarabine

Arm Description

18F-Clofarabine as PET imaging agent for measuring the activity of deoxycytidine kinase (DCK) in various normal and abnormal tissues in cancer participants before and after therapy

Outcomes

Primary Outcome Measures

Evaluate CFA as a PET imaging agent

Establish the image-based biodistribution of CFA, a new tracer for imaging DCK enzyme activity. DCK converts the inactive prodrug clofarabine into its active form. Thus, the degree of DCK expression in normal and abnormal tissues may predict drug effects and effectiveness. The uptake of the radiotracer (SUVs) will be measured quantitatively from PET images taken at 60 min post-injection of [18F]CFA.

Secondary Outcome Measures

Correlate CFA uptake with conventional imaging

Correlate CFA uptake with conventional anatomic imaging using RECIST criteria to establish change over time and differences from participants' baseline scans.

Correlate CFA uptake with PFS

Correlate changes in CFA uptake (SUV) with disease progression as determined by standard of care surveillance imaging.

Correlate CFA uptake with OS

Correlate changes in CFA uptake with participant outcomes as measured by all cause mortality/overall survival (OS).

Adverse Events

Proportion of participants who develop any side effects/adverse events associated with radiotracer infusions.

Full Information

NCT ID

NCT05065736

First Posted

September 23, 2021

Last Updated

July 10, 2023

Sponsor

Omar Mian

1. Study Identification

Unique Protocol Identification Number

NCT05065736

Brief Title

Using a PET Imaging Agent, 18F-Clofarabine (CFA), to Measure Deoxycytidine Kinase Activity in Metastatic Cancer

Official Title

18F-Clofarabine (CFA) as a PET Imaging Agent to Measure Deoxycytidine Kinase (DCK) Activity in Metastatic Cancer, as a Candidate Predictive Biomarker for Response to DCK-dependent Drugs Such as Gemcitabine

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 27, 2022 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Omar Mian

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to evaluate whether a new type of imaging study, called 18F-Clofarabine (CFA) PET/CT, can be used to image cancer pyrimidine metabolism in participants. PET (positron emission tomography) imaging is a way of looking at cancers that can reveal cancer metabolism. Presently, however, there are no imaging agents in routine use to look at an aspect of cancer metabolism (pyrimidine metabolism) that dictates whether certain cancer drugs, e.g., gemcitabine, are likely to be taken into the cancer cells. This clinical trial will be testing whether 18F-Clofarabine (CFA) could be an imaging agent to measure this aspect of cancer metabolism.

Detailed Description

The participants will receive a CFA injection into a vein in their arm. The imaging drug is attracted to and taken into certain cells in the body, including cancer cells. 18F-Clofarabine (CFA) is experimental because it is not approved by the Food and Drug Administration (FDA). The participants will be observed for side effects, and about 1 hour later, they will receive a PET/CT scan. Additionally, they will be contacted the next day to inquire again about any side effects. If the participant's routine care involves repeat imaging of cancer, then the CFA PET/CT scan will be repeated at that time, which could be a month to about 4 months after the first CFA PET/CT scan.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Cancer, Carcinoma, Adenocarcinoma

Keywords

18F-Clofarabine, Diagnostic Imaging, Cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

4 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

18F-Clofarabine

Arm Type

Experimental

Arm Description

18F-Clofarabine as PET imaging agent for measuring the activity of deoxycytidine kinase (DCK) in various normal and abnormal tissues in cancer participants before and after therapy

Intervention Type

Drug

Intervention Name(s)

18F-Clofarabine

Intervention Description

The participants enrolled will receive a baseline CFA PET/CT evaluation. Then, the participants will undergo the routine follow up would normally occur for their cancer and its treatment. If this routine follow up and care involves repeat imaging of the cancer, then the CFA PET/CT scan will be repeated at that time (timed according to standard-of-care follow-up imaging), which is expected between a month to about 4 months after the first CFA PET/CT scan. The study period will end 24 hours after this repeat PET/CT scan.

Primary Outcome Measure Information:

Title

Evaluate CFA as a PET imaging agent

Description

Time Frame

up to 60 minutes after CFA PET

Secondary Outcome Measure Information:

Title

Correlate CFA uptake with conventional imaging

Description

Correlate CFA uptake with conventional anatomic imaging using RECIST criteria to establish change over time and differences from participants' baseline scans.

Time Frame

up to 3 months after CFA PET

Title

Correlate CFA uptake with PFS

Description

Correlate changes in CFA uptake (SUV) with disease progression as determined by standard of care surveillance imaging.

Time Frame

up to 12 months after CFA PET

Title

Correlate CFA uptake with OS

Description

Correlate changes in CFA uptake with participant outcomes as measured by all cause mortality/overall survival (OS).

Time Frame

up to 12 months after CFA PET

Title

Adverse Events

Description

Proportion of participants who develop any side effects/adverse events associated with radiotracer infusions.

Time Frame

within 48 hrs of radiotracer administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically or cytologically proven carcinoma or adenocarcinoma. Histologies other than carcinoma/adenocarcinoma will not be eligible. Subjects must have metastatic disease, confirmed by imaging, typically a CT scan of the chest/abdomen/pelvis. Subjects must have measurable disease per RECIST 1.1 Over 18 years of age ECOG performance status 0-1 Adequate organ function as defined by the following criteria: Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) <= 2.5 x laboratory upper limit of normal (ULN) Total serum bilirubin <= 2.0 x ULN Absolute neutrophil count (ANC) >= 1500/uL Platelets >= 75,000/uL Hemoglobin >= 8.0 g/dL Serum calcium <= 12.0 mg/dL Serum creatinine <= 2.9 mg/dL Subjects must have the ability to understand and the willingness to sign a written informed consent document Patient is able to remain still for the duration of the imaging procedure (up to one hour). Exclusion Criteria: Within 6 months prior to enrollment on this study: myocardial infarction, severe/unstable angina, severe peripheral vascular disease (claudication) or procedure on peripheral vasculature, coronary/peripheral artery bypass graft, New York Heart Association grade II or greater congestive heart failure, cerebrovascular accident or transient ischemic attack, clinically significant bleeding or pulmonary embolism. Pregnancy or breastfeeding (pregnant or breastfeeding women are excluded from this study because study drugs have the potential for teratogenic or abortifacient effects. Other severe acute or chronic medical or psychiatric conditions or laboratory abnormalities that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Omar Mian, MD

Organizational Affiliation

Cleveland Clinic, Case Comprehensive Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cleveland Clinic, Case Comprehensive Cancer Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

This is a feasibility study of a novel PET-scan imaging agent and IPD is not needed for interpretation of the data

Learn more about this trial

Using a PET Imaging Agent, 18F-Clofarabine (CFA), to Measure Deoxycytidine Kinase Activity in Metastatic Cancer

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