Neoplasms

All Conditions

Digestive System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Nervous System Diseases

Skin and Connective Tissue Diseases

Blood and Lymph Conditions

Symptoms and General Pathology

Rare Diseases

Carcinoma

Carcinoma, Hepatocellular

Cholangiocarcinoma

Urinary Bladder Neoplasms

Thyroid Neoplasms

Thyroid Diseases

Neuroendocrine Tumors

Carcinoma, Transitional Cell

Pleural Neoplasms

Brain Neoplasms

Skin Neoplasms

Thymoma

Thymus Neoplasms

Testicular Neoplasms

Adrenal Gland Neoplasms

Neoplasms, Unknown Primary

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Endocrine System Diseases

Skin Diseases

Genital Neoplasms, Male

Genital Diseases

Genital Diseases, Male

Testicular Diseases

Gonadal Disorders

Respiratory Tract Neoplasms

Thoracic Neoplasms

Pleural Diseases

Respiratory Tract Diseases

Neoplasm Metastasis

Neoplastic Processes

Lymphatic Diseases

Adrenal Gland Diseases

Bile Duct Cancer

Neuroendocrine Tumor

Transitional Cell Carcinoma

Adrenal Cancer

Neuroepithelioma

All Drugs and Chemicals

Fluorodeoxyglucose F18

FAPI-46

Radiopharmaceuticals

Patients receive 68Ga-FAPi-46 intravenously (IV), and then undergo PET/computed tomography (CT) over 20-90 minutes. On another day, patients receive 18F-FDG and then undergo PET/computed tomography (CT) according to standard of care procedures (if applicable).

Computed Tomography

Gallium Ga 68 FAPi-46

Positron Emission Tomography

18F-FDG

Ethan Lam

Stephanie Lira

Jeremie Calais

This exploratory study investigates how an imaging technique called 68Ga-FAPi-46 PET/CT can determine where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulates in normal and cancer tissues in patients with cancer. Because some cancers take up 68Ga-FAPi-46 it can be seen with PET. FAP stands for Fibroblast Activation Protein. FAP is produced by cells that surround tumors (cancer associated fibroblasts). The function of FAP is not well understood but imaging studies have shown that FAP can be detected with FAPI PET/CT. Imaging FAP with FAPI PET/CT may in the future provide additional information about various cancers.

PRIMARY OBJECTIVE:

I. To define the biodistribution of gallium Ga 68 fibroblast activation protein inhibitor (FAPi)-46 (68Ga-FAPi-46) in normal and cancer tissues of patients with various malignancies.

SECONDARY OBJECTIVES:

I. To evaluate the degree of 68Ga-FAPi-46 accumulation observed by positron emission tomography (PET) imaging as opposed to the amount of FAP in excised cancer tissue.

II. To assess the 68Ga-FAPI-46 biodistribution correlation with 18F-FDG biodistribution and to define the frequency of the following phenotypes (FAP+/ FDG+, FAP-/ FDG+, FAP+/ FDG-, FAP-/ FDG-)

EXPERIMENTAL OBJECTIVE:

To assess the correlation of 68Ga-FAPI-46 biodistribution with 68Ga-DOTATATE or 18F-DOPA (FDOPA), depending on the specific indication in patients who had them available

OUTLINE:

Patients receive 68Ga-FAPi-46 intravenously (IV), and then undergo PET/computed tomography (CT) over 20-90 minutes. On another day, patients receive 18F-FDG and then undergo PET/computed tomography (CT) according to standard of care procedures (if applicable).

Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers

PET Biodistribution Study of 68Ga-FAPI-46 in Patients With Different Malignancies: An Exploratory Biodistribution Study With Histopathology Validation

The other PET tracer biodistribution will be described by mean and maximum standardized uptake values (SUVmean and SUVmax). The SUV of FAPI PET and the other PET tracers will be tested for correlation.

Will be quantified by mean and maximum standardized uptake values (SUVmean and SUVmax).

Will be correlated with FAP expression in surgically removed or biopsy derived tumor tissue.

2. To assess the 68Ga-FAPI-46 biodistribution correlation with 18F-FDG biodistribution and to define the frequency of the following phenotypes (FAP+/ FDG+, FAP-/ FDG+, FAP+/ FDG-, FAP-/ FDG-)

Jonsson Comprehensive Cancer Center

Recurrence

Lung Neoplasms

Disease Attributes

Lung Diseases

Participants and caregivers undergo embedded palliative care comprising symptom management (physical and psychological), advanced directives and goals of care discussion, caregiver support, and referral for adjunctive supportive services as needed at each clinic visit.

Palliative Therapy

Questionnaire Administration

Carolyn Presley, MD

This trial studies how well embedded palliative care works in managing symptoms in participants with stage III-IV thoracic malignancies that has come back and their caregivers. Embedded palliative care may improve distress and anxiety in participants and caregivers.

PRIMARY OBJECTIVES:

I. To determine feasibility of embedding a palliative care (PC) physician within the James Thoracic Oncology Clinic.

II. To assess patient and caregiver outcomes over a 12-month period within an embedded onco-palliative care clinic model.

III. To evaluate and describe clinician attitudes and beliefs regarding utilization of embedded palliative care as well as symptoms of provider burnout.

IV. To analyze health care utilization among participants receiving embedded onco-palliative care.

OUTLINE:

Participants and caregivers undergo embedded palliative care comprising symptom management (physical and psychological), advanced directives and goals of care discussion, caregiver support, and referral for adjunctive supportive services as needed at each clinic visit.

After completion of study, patients are followed for up to 1 year.

Embedded Palliative Care in Managing Symptoms in Participants With Recurrent Stage III-IV Thoracic Malignancies and Their Caregivers

Embedded Palliative Care in the Management of Advanced Thoracic Malignancies

Acceptance will be evaluated utilizing provider surveys (to capture provider opinions on palliative care utilization) as well as rate of enrollment. Preliminary data will be summarized and collected. Confidence intervals will also be calculated for feasibility rates.

Preliminary data will be summarized and collected. Confidence intervals will also be calculated for feasibility rates.

Clinician capacity and productivity will be evaluated by looking at scheduling as well as billing productivity. Preliminary data will be summarized and collected. Confidence intervals will also be calculated for feasibility rates.

Resources required, including patient care rooms and nursing support will also be evaluated. Preliminary data will be summarized and collected. Confidence intervals will also be calculated for feasibility rates.

Will be assessed using Supportive care screen.

Will be assessed using Functional Assessment of Cancer Therapy-Lung

Will be assessed using Hospital Anxiety and Depression Scale (HADS)

Will be assessed using National Comprehensive Cancer Network distress thermometer

Anxiety assessed using the Hospital Anxiety and Depression Scale

Depression assessed using the Hospital Anxiety and Depression Scale

Functional status assessment using Functional Activities Scale (FAS)

Caregiver needs assessment using Supportive Care Needs Survey - Patients \& Caregivers (SCNC-P\&C)

Ohio State Palliative Care Provider survey used to assess perceived barriers to referral

Will be captured using Integrated Health Information Systems electronic medical record data as well as patient reported events.

evaluate the challenges for patients, caregivers and treating oncologist in embedded palliative care

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers	NCT04459273	Bladder Carcino... Cervical Carcin... Cholangiocarcin... Hematopoietic a... Hepatocellular ... Malignant Adren... Malignant Brain... Malignant Pleur... Malignant Skin ... Malignant Solid... Malignant Testi... Malignant Thymu... Neuroendocrine ... Thyroid Gland C... Urothelial Carc... Cancer of Unkno...	Computed Tomogr... Gallium Ga 68 F... Positron Emissi... 18F-FDG	18 Years -	Jonsson Comprehensive Cancer Center
Embedded Palliative Care in Managing Symptoms in Participants With Recurrent Stage III-IV Thoracic Malignancies and Their Caregivers	NCT04662645	Caregiver Malignant Pleur... Metastatic Thym... Recurrent Lung ... Recurrent Thymi... Stage III Lung ... Stage IIIA Lung... Stage IIIB Lung... Stage IIIC Lung... Stage IV Lung C... Stage IVA Lung ... Stage IVB Lung ...	Palliative Ther... Questionnaire A...	18 Years -	Ohio State University Comprehensive Cancer Center

Spots Global Cancer Trial Database for malignant pleural neoplasm