Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

All Drugs and Chemicals

Fluorodeoxyglucose F18

Radiopharmaceuticals

Participants will receive 4 different techniques of diagnosis: Fludeoxyglucose (F-18 FDG) PET/MRI, Sodium Acetate (C-11 acetate) PET/CT, C-11 PET/MRI, and F-18 FDG PET/CT. Each participant will receive both PET drugs by both diagnostic techniques and is therefore included in the analysis population for the four reporting groups.

Route of administration is intravenous. Dose of each injection will be the standard 5 to 10 millicurie (mCi).

Fludeoxyglucose PET CT

Route of administration is intravenous. Dose of each injection will be 10 mCi (370 MBq).

Sodium Acetate C11 PET CT

Fludeoxyglucose PET MRI

Sodium Acetate C11 PET MRI

Michael C Roarke

Investigators are doing this study to determine which of four imaging techniques: Fludeoxyglucose Positron Emission Tomography (18 FDG PET) computerized tomography (CT), 18 FDG PET Magnetic resonance imaging (MRI), C-11 acetate PET CT, and C-11 acetate PET MRI) is the best test for finding sites of active myeloma disease.

Participants who are clinically scheduled to undergo F-18 FDG PET/CT myeloma evaluation will also undergo F-18 FDG PET/MRI, and C-11 acetate PET CT/MRI. On Day 1 of study, participants will undergo F-18 FDG PET/CT-MRI. F-18 FDG radiopharmaceutical is infused intravenously, followed by a 60 minute waiting uptake phase. After 60 minutes, participant will undergo PET/CT imaging for 30 minutes. At 90 minutes, participant will undergo PET/MRI imaging for 30 minutes. On Day 2 of study, participants will undergo C-11 PET/CT-MRI. C-11 radiopharmaceutical is infused intravenously, followed by a 10 minute uptake phase. After 10 minutes, participant will undergo PET/CT imaging for 30 minutes, followed by a 60 minute pause with the participant at rest. At the end of 60 minute pause, the participant is given the second C-11 acetate infusion, followed by a 10 minute waiting uptake phase. After 10 minutes, participant will undergo PET/MRI imaging for 30 minutes. On Day 3, study team member makes a phone call to participant for follow up.

Comparison of F-18 FDG and C-11 Acetate PET in Multiple Myeloma

Comparison of F-18 FDG PET CT and PET MRI With C-11 Acetate PET CT and PET MRI in the Diagnosis of Active Multiple Myeloma Disease: a Pilot Study

The number of lesions detected in the scans will be averaged for each technique. Two techniques (scans) will be tested on Day 1 and two techniques (scans) will be tested on Day 2.

The visual image analysis scale has a range of 0-4: (0 no uptake; 1 benign, 2 probably benign, 3 probably malignant, 4 malignant).

Michael C Roarke, MD

Sponsor-Investigator

New diagnosis, high risk smoldering MM, relapse as defined by investigator. Participants received 4 different techniques of diagnosis: Fludeoxyglucose (F-18 FDG) PET/MRI, Sodium Acetate (C-11 acetate) PET/CT, C-11 PET/MRI, and F-18 FDG PET/CT. Each participant received both PET drugs by both diagnostic techniques and is therefore included in the analysis population for the four reporting groups.

Fludeoxyglucose: Route of administration was intravenous. Dose of each injection was the standard 5 to 10 millicurie (mCi).

Sodium Acetate C11: Route of administration was intravenous. Dose of each injection was 10 mCi (370 MBq).

Multiple Myeloma (MM) Patients

Age, Continuous

Sex: Female, Male

White

Black or African American

Hispanic or Latino

Race/Ethnicity, Customized

United States

Region of Enrollment

Michael C. Roarke, M.D.

C-11 acetate PET CT

C-11 acetate PET MRI

18 FDG PET CT

18 FDG PET MRI

Each participant received both PET drugs by both diagnostic techniques (scans) and is therefore included in the analysis population for the four reporting groups.

Mean Multiple Myeloma Lesions Detected

Visual Image Analysis of Detected Multiple Myeloma Lesions

Overall Study

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Stranded palladium seed interstitial radioactive seed implant to seroma with margin with 3 dimensional ultrasound and CT guidance

Interstitial implantation of stranded palladium 103 seeds in seroma with a margin

Stranded palladium seed interstitial implant

guidance of placement of interstitial needles in breast

3 dimensional breast ultrasound

Breast CT for planning and assessing interstitial implantation of radioactive seeds

Computerized tomography (CT)

Juanita Crook, MD

Permanent Breast Seed Implant (PBSI) has been demonstrated to be a well accepted and well tolerated form of partial breast radiotherapy. This protocol aims to build on the initial experience and to further refine the technique and collect toxicity and cost data, especially in comparison to alternate forms of breast radiotherapy.

25 women with low stage (pT1pN0) breast cancer, grade 1 or 2, will be accrued for adjuvant partial breast radiotherapy using PBSI and prospectively followed for 5 years. The primary aims is to evaluate implant quality according to recognized dosimetric parameters. Secondary aims include elaboration of approaches to different technical scenarios imposed by variation in seroma size, shape and location within the breast (expanding the technical manual to include recommended approaches to implants in different sectors of the breast and in different size breasts), incorporation of the use of live 3D ultrasound in the procedure (as opposed to current use of 2D US), assessment of patient acceptance and quality of life, physician assessment of cosmesis, assessment of toxicity, and recording of cost to the patient and health care system compared to alternate forms of breast radiotherapy.

Partial Breast Irradiation Using Interstitial Permanent Palladium-103 Seed Implant

Post implant CT evaluation to report dosimetric parameters including the minimum dose in Gray to 90% of the target volume (D90) and the percentage of the target volume (seroma, seroma with 5 mm margin, seroma with 10 mm margin) receiving 100% of the prescribed dose (V100).

US and CT evaluation to record the range of seroma volumes and quadrant location in the breast acceptable for implantation

Post implant CT evaluation describing dosimetric parameters (D90 and V100 as above in Outcome 1) with the use of 3D ultrasound and with 2D ultrasound

Physician assessed using the questionnaire from the Radiation Therapy Oncology Group (RTOG) and National Surgical Adjuvant Breast Project (NSABP)

Physician assessed using the Common Terminology Criteria for Adverse Events (CTCAE V4) form

Patient assessed using the RTOG/NSABP Breast Cancer Quality of Life Assessment form

Post implant CT assessment describing calculated doses to lung, ribs and heart described as the highest dose to 1 cc of the specific organ tissue and skin dose recorded as an area 1 cm by 1 cm by 2 mm thick (1cmx1cmx0.2cm)

Cost to health care system (Canadian dollars) and patient (expenses and lost wages in Canadian dollars)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparison of F-18 FDG and C-11 Acetate PET in Multiple Myeloma	NCT03262389	Multiple Myelom...	Fludeoxyglucose... Sodium Acetate ... Fludeoxyglucose... Sodium Acetate ...	20 Years -	Mayo Clinic
Partial Breast Irradiation Using Interstitial Permanent Palladium-103 Seed Implant	NCT02297672	Early Stage Bre...	Stranded pallad... 3 dimensional b... Computerized to...	55 Years - 80 Years	British Columbia Cancer Agency
Comparison of F-18 FDG and C-11 Acetate PET in Multiple Myeloma	NCT03262389	Multiple Myelom...	Fludeoxyglucose... Sodium Acetate ... Fludeoxyglucose... Sodium Acetate ...	20 Years -	Mayo Clinic
Partial Breast Irradiation Using Interstitial Permanent Palladium-103 Seed Implant	NCT02297672	Early Stage Bre...	Stranded pallad... 3 dimensional b... Computerized to...	55 Years - 80 Years	British Columbia Cancer Agency

Spots Global Cancer Trial Database for computerized tomography (ct)