A Pilot Study Of 1-(2-[18f]Fluoroethyl)-L-Tryptophan PET/CT Imaging In Human Cancers

Cancer Categories

Brain and Nervous System,Breast,Genitourinary (GU)

Karmanos Trial ID

2022-010

NCT ID

NCT05556473

Age Group

Adult

Scope

Local

Phase

Phase I

Principal Investigator

Juhasz, Csaba

Objective:

Primary Objective:

The primary objective of this pilot study is to evaluate tracer uptake and metabolic trapping characteristics based on [18F]FETrp PET/CT in patients with intra- and extracranial cancers; specifically, to evaluate whether the tumors show increased tracer uptake as measured by both tumor maximal and mean standardized uptake value (SUVmax and SUVmean, respectively), as compared to non-tumor tissues. In the special case of breast tumor imaging, the primary objective will be the correlation between the tumors’ SUV values and the apparent volume of distribution (VD’) which will be calculated using kinetic modeling analysis.

Secondary Objectives:

Using dynamic PET imaging to establish the optimal time frame when tracer uptake peaks.
Using compartmental modeling (in tumors with the left ventricle of the heart in the field-of-view) to measure tracer transport and trapping variables.
To obtain first in human safety, biodistribution, and radiation dosimetry data for [18F]FETrp PET/CT.

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Eligibility

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.

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.

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

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

-Active inflammatory bowel disease (Crohn's or Ulcerative colitis) involving the rectum.

Locations

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Detroit, MI 48201
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Phone: 800-527-6266

Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

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Farmington Hills, MI 48334
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Phone: 800-527-6266

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