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F-Tryptophan PET/CT in Human Cancers

Primary Purpose

Intracranial Glioma, Metastatic Brain Tumor, Breast Cancer

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
1-(2-[18F]FLUOROETHYL)-L-Tryptophan
Sponsored by
Barbara Ann Karmanos Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Intracranial Glioma

Eligibility Criteria

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

Inclusion Criteria:

  • Age ≥18 years.
  • Targeted lesion (tumor) is at least 1 cm in diameter as shown by clinical imaging.
  • Patient is able to lie in the PET/CT scanner for at least 70 minutes while undergoing scanning.
  • Women of childbearing potential must not be pregnant or breastfeeding.
  • Recent anatomic imaging with visible disease (tumor) for comparison with the PET/CT. .
  • Physical exam within 28 days of PET imaging, CBC and Multiphasic (including electrolytes, BUN, creatinine, total bilirubin, AST and ALT) within 14 days.
  • Patients must sign an informed consent indicating that they are aware of the investigational nature of this study.

Inclusion Criteria Specific for Intracranial Tumors - Clinical and MRI diagnosis of an intracranial lesion suspicious for a brain tumor, including gliomas or metastatic brain tumors; primary, residual, or recurrent brain tumors (judged by clinical imaging) will qualify.

Inclusion Criteria Specific for Extracranial Neuroendocrine Tumors:

  • Histopathologically confirmed, well-differentiated metastatic neuroendocrine tumor.
  • ECOG performance status of 2 or better.
  • Patients receiving stable-dose somatostatin analogs (SSAs, long-acting release [LAR], depot) for >3 months before enrollment may be enrolled on the study, but such treatment is not required.

Inclusion Criteria specific for Extracranial Primary Breast tumors:

  • Clinical and radiological diagnosis of a breast cancer
  • ECOG performance status of 2 or better.

Exclusion Criteria:

  • Patients who are pregnant or lactating are excluded.

Exclusion Criteria Specific for Intracranial Tumors:

  • Severe increased intracranial pressure, status epilepticus, or other symptoms requiring emergency or urgent intervention.
  • Tumor surgery or radiation within 1 month prior to the PET scan

Exclusion Criteria Specific for Extracranial Neuroendocrine Tumors:

  • Tumor-directed therapy within 3 months to the area of planned imaging.
  • Ongoing treatment with a targeted agent (e.g., sunitinib or everolimus) or receiving cytotoxic chemotherapy (e.g., capecitabine or temozolomide).
  • Use of telotristat ethyl (a tryptophan-hydroxylase inhibitor) within one month.

Exclusion Criteria for Extracranial Primary Breast tumors:

-Recent (within 1 month) tumor resection or radio-chemotherapy (acute/subacute post-treatment inflammatory changes may cause false positive increases on PET).

Sites / Locations

  • Karmanos Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

[18F]FETrp PET radiotracer

Arm Description

All participants will receive the tracer to evaluate the uptake of [18F]FETrp PET/CT on intra- and extracranial cancers.

Outcomes

Primary Outcome Measures

The percent difference in tracer uptake values between the tumor mass and the background (non-tumor tissue)
The percent difference in 1-(2-[18F]fluoroethyl)-L-tryptophan tracer standardized uptake values, measured between tumor and non-tumor (normal) tissues by PET/CT imaging, in each subject, will be calculated. Mean and standard deviation of the percent differences will be calculated for each tumor type.
Correlation between the 1-(2-[18F]fluoroethyl)-L-tryptophan tracer uptake values and the tracer transport rates measured in the same breast tumor tissue.
The 1-(2-[18F]fluoroethyl)-L-tryptophan tracer standardized uptake values and the volume of distribution (characterizing the tracer transport rates) will be measured by PET/CT imaging in the same breast tumor tissues, and the correlation of these two measures will be calculated.

Secondary Outcome Measures

Radiation doses to the various organs.
Radiation doses received by the various organs (heart, lungs, pancreas, gallbladder, liver, small intestines, kidneys, muscle, bladder, ovaries/testes) will be measured from the dynamic 1-(2-[18F]fluoroethyl)-L-tryptophan PET/CT images. Mean and standard deviation of the radiation doses will be calculated for each organ.
Overall radiation dose to the study participants.
Overall radiation dose received by the study participants from the PET/CT scan will be calculated from the dynamic 1-(2-[18F]fluoroethyl)-L-tryptophan PET/CT images. Mean and standard deviation of the overall radiation dose will be calculated.

Full Information

First Posted
September 22, 2022
Last Updated
February 21, 2023
Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05556473
Brief Title
F-Tryptophan PET/CT in Human Cancers
Official Title
A Pilot Study of 1-(2-[18f]Fluoroethyl)-L-Tryptophan PET/CT Imaging In Human Cancers
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 29, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Imaging procedures such as 1-(2-[18F]FLUOROETHYL)-L-Tryptophan PET/CT in patients with cancers may help doctors assess a patient's response to treatment and help plan the best treatment in the future. The purpose is to see if there can be a better differentiation of tumor and non-tumor tissue where the tumor tissue has a higher uptake of Tryptophan.
Detailed Description
In this research study, we will compare the uptake of the tracer on F-Tryp PET/CT in patients with cancers; specifically, to evaluate whether the tumors show increased tracer uptake as compared to non-tumor tissues, using F-Tryp PET/CT. Additionally, we will evaluate the biodistribution (i.e. track where the tracer has traveled in the body) and radiation dosimetry (i.e., absorbed dose of tracer in tissue). These changes may be compared with results of the physical examination and scans (CT and MRI or standard clinical PET) that are done as part of routine clinical care or as part of other studies. Pictures (images) from the PET scan will be made showing the distribution throughout the body of substances containing a small amount of radioactive material.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Glioma, Metastatic Brain Tumor, Breast Cancer, Neuroendocrine Tumors, Rectal Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
[18F]FETrp PET radiotracer
Arm Type
Experimental
Arm Description
All participants will receive the tracer to evaluate the uptake of [18F]FETrp PET/CT on intra- and extracranial cancers.
Intervention Type
Drug
Intervention Name(s)
1-(2-[18F]FLUOROETHYL)-L-Tryptophan
Other Intervention Name(s)
[18F]FETrp PET radiotracer
Intervention Description
Radioactive tracer 1-(2-[18F]FLUOROETHYL)-L-Tryptophan 0.14mCi/kg/5MBq/kg injection given one time prior to PET Scan.
Primary Outcome Measure Information:
Title
The percent difference in tracer uptake values between the tumor mass and the background (non-tumor tissue)
Description
The percent difference in 1-(2-[18F]fluoroethyl)-L-tryptophan tracer standardized uptake values, measured between tumor and non-tumor (normal) tissues by PET/CT imaging, in each subject, will be calculated. Mean and standard deviation of the percent differences will be calculated for each tumor type.
Time Frame
During procedure (from right after tracer injection to 1-hour post-injection)
Title
Correlation between the 1-(2-[18F]fluoroethyl)-L-tryptophan tracer uptake values and the tracer transport rates measured in the same breast tumor tissue.
Description
The 1-(2-[18F]fluoroethyl)-L-tryptophan tracer standardized uptake values and the volume of distribution (characterizing the tracer transport rates) will be measured by PET/CT imaging in the same breast tumor tissues, and the correlation of these two measures will be calculated.
Time Frame
During procedure (from right after tracer injection to 1-hour post-injection)
Secondary Outcome Measure Information:
Title
Radiation doses to the various organs.
Description
Radiation doses received by the various organs (heart, lungs, pancreas, gallbladder, liver, small intestines, kidneys, muscle, bladder, ovaries/testes) will be measured from the dynamic 1-(2-[18F]fluoroethyl)-L-tryptophan PET/CT images. Mean and standard deviation of the radiation doses will be calculated for each organ.
Time Frame
During procedure (from right after tracer injection to 1-hour post-injection)
Title
Overall radiation dose to the study participants.
Description
Overall radiation dose received by the study participants from the PET/CT scan will be calculated from the dynamic 1-(2-[18F]fluoroethyl)-L-tryptophan PET/CT images. Mean and standard deviation of the overall radiation dose will be calculated.
Time Frame
During procedure (from right after tracer injection to 1-hour post-injection)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 years. Targeted lesion (tumor) is at least 1 cm in diameter as shown by clinical imaging. Patient is able to lie in the PET/CT scanner for at least 70 minutes while undergoing scanning. Women of childbearing potential must not be pregnant or breastfeeding. Recent anatomic imaging with visible disease (tumor) for comparison with the PET/CT. . Physical exam within 28 days of PET imaging, CBC and Multiphasic (including electrolytes, BUN, creatinine, total bilirubin, AST and ALT) within 14 days. Patients must sign an informed consent indicating that they are aware of the investigational nature of this study. Inclusion Criteria Specific for Intracranial Tumors - Clinical and MRI diagnosis of an intracranial lesion suspicious for a brain tumor, including gliomas or metastatic brain tumors; primary, residual, or recurrent brain tumors (judged by clinical imaging) will qualify. Inclusion Criteria Specific for Extracranial Neuroendocrine Tumors: Histopathologically confirmed, well-differentiated metastatic neuroendocrine tumor. ECOG performance status of 2 or better. Patients receiving stable-dose somatostatin analogs (SSAs, long-acting release [LAR], depot) for >3 months before enrollment may be enrolled on the study, but such treatment is not required. Inclusion Criteria specific for Extracranial Primary Breast tumors: Clinical and radiological diagnosis of a breast cancer ECOG performance status of 2 or better. Inclusion Criteria specific for Rectal tumors: Histologically confirmed colorectal cancer, which is located in the rectum. ECOG performance status of 2 or better. Exclusion Criteria: Patients who are pregnant or lactating are excluded. Exclusion Criteria Specific for Intracranial Tumors: Severe increased intracranial pressure, status epilepticus, or other symptoms requiring emergency or urgent intervention. Tumor surgery or radiation within 1 month prior to the PET scan Exclusion Criteria Specific for Extracranial Neuroendocrine Tumors: Tumor-directed therapy within 3 months to the area of planned imaging. Ongoing treatment with a targeted agent (e.g., sunitinib or everolimus) or receiving cytotoxic chemotherapy (e.g., capecitabine or temozolomide). Use of telotristat ethyl (a tryptophan-hydroxylase inhibitor) within one month. Exclusion Criteria for Extracranial Primary Breast tumors: -Recent (within 1 month) tumor resection or radio-chemotherapy (acute/subacute post-treatment inflammatory changes may cause false positive increases on PET). Exclusion Criteria for Rectal tumors: -Active inflammatory bowel disease (Crohn's or Ulcerative colitis) involving the rectum.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Csaba Juhasz, M.D., Ph.D
Phone
313-966-5136
Email
csaba.juhasz@wayne.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Csaba Juhasz, M.D.,Ph.D
Organizational Affiliation
Barbara Ann Karmanos Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Csaba Juhasz, MD
Phone
313-966-5136
Email
csaba.juhasz@wayne.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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F-Tryptophan PET/CT in Human Cancers

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